Biomedical Engineer Resume Sample

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Adolph Mann
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Work Experience


Senior Biomedical Engineer
06/2015 - PRESENT
San Francisco, CA
  • Utilize knowledge and experience in biomedical engineering to design new medical devices requiring advanced biomaterial input
  • Design, document, and coordinate material design (both specification and manufacturing requirements)
  • Lead cross functional design teams to develop advanced material medical devices
  • Serve as the Technical authority for teams and projects
  • Troubleshoot material selection problems on new and existing products/designs
  • Provide technical direction, based on engineering data and rationale, to manufacturing engineering, production and vendors involved in product development
  • Provide documentation, schedule and supervise fabrication of the initial prototypes to demonstrate concept feasibility, verification and validation requirements
  • Generate ideas and solutions for new products
Biomedical Engineer
06/2010 - 04/2015
Los Angeles, CA
  • Manage relevant material testing for product development and production by establishing and maintaining good test lab practices and procedures
  • Define, design and conduct various tests ensuring products meet requirements and identify opportunities for test improvements
  • Work with R&D engineers and technicians to define, establish and run tests to address various user / product requirements
  • Maintain lab facility and manage spending to meet various project needs
  • Interface with QA and manufacturing engineering to address product change requests resulting from process improvements, CAPAs, etc
  • Work with Hill-Rom’s intellectual property department to develop and patent innovation in the area of support surfaces
  • Provides highly technical and professional services that directly impact the delivery of healthcare affecting several VISN 1 Outpatient facilities that encompass the Central Western Massachusetts
Junior Biomedical Engineer
02/2008 - 02/2010
Houston, TX
  • Work with Legal to create and define patent clearing studies and invention disclosures
  • Create initial drawings or sketches for presentation of product concept to management or patent counsel
  • Investigate critical product/process problems using formal root cause analysis techniques and support sustaining engineering projects on demand
  • Follow GMP, GLP, ISO, FDA, Olympus and Gyrus ACMI operational procedures as required
  • Consult with the appropriate engineering team member to properly design experiments / create test setups, author test protocols, product development reports, verification and validation activities, etc
  • Coordinate design and development efforts with external engineering resources
  • Lead or partner with Marketing and Sales departments to develop and refine Voice of Customer (VOC), understand and define physician needs, user requirements, product specifications, etc

Education


Purdue University North Central
2003 - 2007
Engineer's Degree in Engineering Technology

Professional Skills


  • Use excellent communication skills to effectively explain complex concepts to business counterparts
  • Use strong problem solving skills and programming knowledge to quickly cycle hypotheses through discovery
  • Independent work skills with a strong work ethic, and the ability to perform in a team setting
  • Strong project management skills, including the ability to handle multiple assignments
  • Demonstrated Project Management skills are essential
  • Excellent verbal and written documentation and communication skills in English
  • Strong written and verbal communication skills, as well as the ability to work independently and collaboratively

How to write Biomedical Engineer Resume

Biomedical Engineer role is responsible for clinical, travel, software, microsoft, trials, documentation, engineering, training, manufacturing, education.
To write great resume for biomedical engineer job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Biomedical Engineer Resume

The section contact information is important in your biomedical engineer resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Biomedical Engineer Resume

The section work experience is an essential part of your biomedical engineer resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous biomedical engineer responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular biomedical engineer position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Biomedical Engineer resume experience can include:

  • Identifies, acquires and or develops tools required to effectively develop and test biomedical signal processing systems and subsystems
  • Effectively satisfying the customer's needs for medical equipment
  • Relevant hospital equipment skills for each clinical trial project
  • Experience working with CAD-CAM applications, computer engineering, and electronic interfacing of medical equipment with computers
  • Education and / or experience in the hardware and software design of medical devices, with focus on physiological signal processing systems
  • Experience in an engineering environment

Education on a Biomedical Engineer Resume

Make sure to make education a priority on your biomedical engineer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your biomedical engineer experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school

These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Biomedical Engineer Resume

When listing skills on your biomedical engineer resume, remember always to be honest about your level of ability. Include the Skills section after experience.

Present the most important skills in your resume, there's a list of typical biomedical engineer skills:

  • Skill to effectively communicate both orally and in writing with a wide variety of individuals, including communicating highly technical information
  • Have experience within a hospital environment, together with proven experience in customer service maintenance and/or installation activities
  • Developing and implementing cost effective, appropriate maintenance strategies for healthcare equipment, and evaluating the effectiveness of those strategies
  • Working knowledge of IRB/IACUC processes and submission, clinical data acquisition, BioDesign principles, CAD, and rapid-prototyping skills
  • 3D design experience in CAD software (e.g. FreeForm, Solidworks, Magics, etc)
  • Prior work experience with medical technology start-ups to drive innovation

List of Typical Experience For a Biomedical Engineer Resume

1

Experience For Senior Biomedical Engineer Resume

  • Strong technical documentation skills within a formal quality system (ISO 13485, FDA QSR’s, IEC 62304 etc.)
  • Computer software skills including MS Office
  • Deal effectively with individuals or groups representing widely divergent backgrounds,
  • Effective communicator both in writing and verbally with demonstrated ability to communicate with members at any level of the team
  • Skill in planning, organizing, and directing the work of other professionals, and in planning, organizing, and directing studies
  • Experience in grant writing and obtaining extramural funding
2

Experience For Manager, Biomedical Engineer Resume

  • Experience in modeling applications using MATLAB and/or Python, NEURON, and finite element modeling tools (e.g., COMSOL)
  • Skill in managing and directing the work of others to accomplish programs goals and objectives
  • BS in mechanical/biomedical engineering or biological science with 5-7 years of relevant experience
  • Highly skilled scientist or engineer with understanding of biomedical device industry
  • Operate data acquisition systems during hardware verification, science verification, and actual data acquisition from human subjects
  • Operate specialized equipment used in tests on human subjects
  • Assist in implementing the Medical Equipment Plan (MEMP) and evaluate the MEMP regularly in terms of objectives, scope, performance and effectiveness
  • Able to contribute to complex projects with demonstrated ability to work independently, as well as, part of a multidisciplinary team
3

Experience For Supervisory Biomedical Engineer Resume

  • Knowledge and demonstrated application of statistical methods
  • Prioritize and complete multiple technical projects
  • Skilled with software and technology development and integration of current and future systems
  • A strong working knowledge of basic engineering principles
  • A strong working knowledge of quantitative data analysis and statistics
  • Skill in managing a biomedical engineering program at the local level
  • Working knowledge of regulatory issues applicable to medical device including ISO 13485, 14971, and FDA Design Controls
  • Including service, system administration, training, and quality assurance
4

Experience For R&d-advanced Biomedical Engineer, Surfaces Resume

  • Providing input on new technologies and creative ideas for system improvement
  • Developing the work performance specifications for a variety of service contractors, including servicing specialized imaging equipment
  • Planning, organizing, and implements new programs and projects affecting the department
  • Reviewing, comparing, and selecting medical equipment for use in the medical center
  • Developing and improving complex medical equipment systems
  • Evaluating functional and operational requirements of medical and engineering systems to establish and confirm specific requirements for final application
5

Experience For Biomedical Engineer Clinical Resume

  • Assisting with implementation of biomedical engineering computer software and software updates
  • Supervising biomedical engineering personnel
  • Administering the Quality Assurance and Continuous Quality Management program
  • Facilitating the introduction of new medical equipment into the medical center
  • Developing policies and guidelines for the installation, maintenance and electrical safety or a wide variety of equipment systems
  • Assisting with implementation of preventative maintenance programs for all medical equipment
  • Ensuring compliance with the Safe Medical Device Act
  • Supervising activities of approximately 10 subordinates
6

Experience For Biomedical Engineer Apprentice Resume

  • Key member of Engineering staff, having direct authority to accomplish assignments affecting health care throughout the facility
  • Provides a wide range of technical input and oversight when analyzing benefits and costs of accomplishing work in-house vs. contracts
  • Utilize Excel and Minitab to compile and create trending information for input into the sustaining products organization
  • Identify emerging technologies to support and complement existing and future R&D initiatives
  • Prepares applications, manuscripts, presentations, abstracts, and reports (including data analysis) for funding applications, press, and scientific publication
  • Utilizes engineering training and expertise to develop and improve devices for medical/surgical intervention, interfaces, and data collection
  • Apply knowledge of BEE work practices, policies, procedures and standards related to OEH and ionizing and non-ionizing radiation
  • Conduct capital asset and infrastructure planning for medical equipment spanning initial
  • Comfortable in participating in the design, modification, and performance of laboratory engineering projects
7

Experience For Biomedical Engineer Intern Resume

  • To travel CONUS or O-CONUS to conduct testing and research, attend working groups meetings, workshops, conferences, or other relevant meetings
  • Knowledge of the basic physics and engineering of MRI
  • Interact directly with surgeons regarding clinical details of reconstructive surgery
  • Organize the initiation of 3D printing builds and the finalization of parts to ensure on time shipment of parts
  • Work with life scientists, chemists, and medical scientists to research the engineering aspects of biological systems of humans and animals
  • Small computer programming projects, related to data acquisition, management, and analysis
  • Design and 3D print custom devices for sample/subject positioning
  • Develop and document reports and analyses summarizing research study test sessions
8

Experience For Junior Biomedical Engineer Resume

  • Liaises with all corporate and academic colleagues on biomedical engineering research projects
  • Knowledge of the most complex and specialized clinical technology including service, system administration,
  • Knowledge of the principles, practices and theories in evaluating preclinical study designs and resultant data
  • Works primarily in office setting with significant use of computer
  • Initiates, plans, organizes, and implements new programs and projects that affect the department
  • Organizes projects of broad scope and objectives that affect many levels of medical and administrative staff
  • Specifies, designs, develops, supports and validates new and improved sensor and signal processing hardware and software for ZOLL physiological monitoring and treatment products. Provides the technical focus and direction for the development efforts required for a project
  • Experience with C/C++, Object Oriented Design, and Matlab, in a PC environment
  • Embedded hardware design knowledge and experience (e.g. AID, R, SC processors, DSP processors)
9

Experience For R&d-senior Biomedical Engineer Resume

  • Supports project teams and quality assurance in resolution of field issues
  • Innovative thinker with a focus on reach and investigations and analysis
  • Repairs, installs, maintains, calibrates, and inspects diagnostic imaging systems. Uses knowledge and experience to test and maintain imaging equipment not having specific maintenance procedures. Inventories and completes documentation for entry into automated Maintenance Management Systems
  • Performs preventive maintenance and electrical safety testing of diagnostic imaging technologies. Reviews outcome of preventive maintenance actions and makes recommendations concerning changes to preventive maintenance schedules, procedures, or documentation. Restores equipment to manufacturers' specifications
  • Ensures compliance with all federal/state/local rules and regulations and all applicable policies and procedures governing Kaiser Permanente, National Facilities Services, and Clinical Technology operations. Assists in developing and maintaining a comprehensive and cost-effective Imaging Equipment Program to comply with same
  • Collaborates with IT regarding Information Systems to ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA). Ensures proper connectivity of imaging systems. Works with PACs administrators to address/resolve imaging connectivity issues
10

Experience For Biomedical Engineer Ct / mr Resume

  • Skill in negotiating as a group leader with the regulated industry for acceptance of recommendations and requirements which involve substantial changes in established processes and activities, and conflict with the desires and goals of the regulated industry
  • Experience with MRI research projects
  • Apply engineering knowledge of scientific principles to establish efficient working methods to project needs
  • Create and revise existing clinical study and usability protocols to meet product development and project needs
  • Communicate orally as a group leader
  • Conduct medical literature searches, review and analyze field data for use in product investigations
  • Provide guidance to the clinical team in the review and selection of clinical study protocols to meet project team objectives

List of Typical Skills For a Biomedical Engineer Resume

1

Skills For Senior Biomedical Engineer Resume

  • Set and effectively communicate priorities in a changing environment
  • Mechanical design and analysis experience utilizing 3D CAD design suites (Solidworks or equivalent software) and FEA experience
  • Demonstrated experience in neural engineering is highly desirable
  • Demonstrated experience in the medical device industry
  • Strong technical competency and demonstrated project leadership competency is required with a sense of personal accountability
  • Work effectively with people from various disciplines and educational backgrounds
2

Skills For Manager, Biomedical Engineer Resume

  • Effectively employ Safety Management System concepts and principles to all areas of operation
  • 6+ months experience testing/repairing medical devices
  • Develops and maintaining a curriculum for a continuing education program that addresses the safe and effective use of medical equipment and/or technology
  • Skilled with using measurement equipment such as oscilloscopes, voltmeters, calibration instruments
  • Strong attention to detailed
3

Skills For Supervisory Biomedical Engineer Resume

  • Previous laboratory research experience, preferably in areas relating to biomedical engineering, cardiopulmonary resuscitation, and cardiac arrest
  • Demonstrated background and knowledge on machine learning approaches and/or advanced signal processing algorithms
  • Experience working with medical devices or conducting biomedical research
  • Coursework in Engineering or Graphic Design with some experience in CAD and 3D applications
  • Experience in Biomedical Engineering
  • Experience in publishing peer-reviewed scientific journals
  • Demonstrated success working in a highly collaborative environment, with a track record of accomplishments with measurable business impact
4

Skills For R&d-advanced Biomedical Engineer, Surfaces Resume

  • Experience working in a clinical environment (Emergency Medical System, EMS, hospital, clinic)
  • Experience in biological science research team project or working in biological research labs highly desired
  • Experience in clinical research and CITI certified
  • Product design experience in the medical device industry or equivalent
  • Demonstrated familiarity of design controls within a regulated industry
  • 1 – 3 years of hands on experience in cell culture and aseptic technique
  • Experience in MatLAB and OpenSIM
  • Some experience in cardiac electrocardiogram (ECG) interpretation
  • Experience with Department of Defense medicine and Federal health agencies
5

Skills For Biomedical Engineer Clinical Resume

  • Project Management experience with MS Project software or similar Project Management programs
  • Initiate new ideas and approaches, and demonstrate resourcefulness
  • Managing, maintaining, operating and modifying high energy acceleration test platforms and equipment
  • Serving as principal advisor to the Director, ODE, on all major issues involving the automation of the review process of FDA/CDRH/ODE regulated products
  • Working and communicating closely with the team for progress and results
  • Executing biomechanical and/or biomedical protocols and analyzing data
  • Developing biomechanical and/or biomedical protocols to investigate or evaluate human, animal, and/or equipment interactions for injury causation or protection
  • Working with industry and customers on biomechanical/biomedical products, solutions, or cases
  • Provide cutting edge data science thought leadership to a growing team that is developing new insights for Medtronic
6

Skills For Biomedical Engineer Apprentice Resume

  • Responsible for building and maintaining the database of patient outcomes associated with the 3D printing program
  • Provide technical marketing, funding-source development, and maintaining customer and collaborator relations
  • Represents the 3D program by attending and presenting at regional and national conferences for MCHS
  • Represents the 3D program by attending and presenting at regional and national conferences for NCHS
  • Ability to conduct capital asset and infrastructure planning for medical equipment spanning initial concept,
  • Develop test protocols and test equipment for Biomedical Engineering use in incoming inspections and equipment evaluations
  • Advance predictive modeling practices through pattern recognition, data manipulation, and analysis
  • Transfer technical knowledge to others using a variety of tools and techniques
  • Liaisons with vendors to co-develop technologies focusing on pediatric innovations at MCHS
7

Skills For Biomedical Engineer Intern Resume

  • Develops and maintains the clinical workflow for the 3D printing program
  • Works with clinicians, vendors, and marketing department to produce press releases and interviews relevant to program
  • Mentors biomedical engineering teams and other trainees as needed
  • Liaisons with vendors to co-develop technologies focusing on pediatric innovations at NCHS
  • Serve as an official liaison to state and local public health and regulatory organizations in a biomedical engineering field of specialization
  • Familiarity with HIPAA, PHI/PII compliance, etc. is highly desired
8

Skills For Junior Biomedical Engineer Resume

  • Demonstrate an excellent understanding of signal processing and machine learning techniques as well as the physiologic processes and measurements related to biomedical transducers
  • Provide oversight for multiple projects at the same time, helping the team meet deadlines as agreed with our development and project partners
  • Integrate data from multiple sources to support discriminative modeling of complex physiologic systems
  • Expert knowledge of, and the ability to interpret and apply, complex codes, regulations, guidelines and
  • 3D Systems partners with surgeons, healthcare professionals, medical device manufacturers, and medical teaching staff to offer a range of precision healthcare solutions including virtual reality simulators, 3D printed anatomical models, Virtual Surgical Planning, patient-specific surgical guides, instrumentation and implants
9

Skills For R&d-senior Biomedical Engineer Resume

  • 3D Systems partners with surgeons, healthcare professionals, medical device manufacturers, and medical teaching staff to offer a range of precision healthcare solutions, including virtual reality simulators, 3D printed anatomical models, virtual surgical planning, patient-specific surgical guides, instrumentation and implants
  • Biomedical Engineer (Clinical): Supports and advances patient care by applying engineering and managerial skills to healthcare technology as demonstrated by at least 4 of the following major responsibilities
  • Develop a curriculum for a continuing education program that addresses the safe and effective use of medical equipment and/or technology
  • Manage a recall and safety alert program for medical devices including medical device
  • Conduct an equipment management program that meets current JCAHO and NFPA requirements
10

Skills For Biomedical Engineer Ct / mr Resume

  • Analyze organizational and operational problems and recommend timely and economical solutions involving medical equipment spanning initial concept, installation, and effective implementation of complex medical equipment
  • Advanced knowledge of, and ability to interpret and apply, relevant codes, regulations, guidelines, and standards associated with biomedical engineering to support the needs of 1 or more facility
  • B. Ability to manage resources, i.e., space, equipment, supplies, staff, at the local level
  • C. Ability to draft and/or recommend local policies and/or directives
  • Successful with interdisciplinary teams to achieve mutual goals
  • Extensive knowledge of CAD-CAM based applications and their utilization in medicine

List of Typical Responsibilities For a Biomedical Engineer Resume

1

Responsibilities For Senior Biomedical Engineer Resume

  • Excellent organizational, analytical reasoning, problem-solving, and conflict management skills
  • Demonstrated SolidWorks experience or other CAD software tools
  • Experience managing, mentoring and leading others
  • D. Skill in managing a biomedical engineering program at the local level
  • Machine Learning/Data Science programming experience with Python, R, Matlab, SAS, Scala, Java or similar stack
  • Experience with medical device product development and tissue engineering, required
2

Responsibilities For Manager, Biomedical Engineer Resume

  • Biological signal processing experience
  • Experience with deep learning architectures
  • Experience with rapid-prototyping technologies like SLA, SLS, EBM, MJP or CJP
  • Experience with rapid-prototyping technologies like SLA, SLS, FDM, EBM
  • Demonstrate working knowledge of product enhancements and manufacturing process refinement
  • Demonstrate working knowledge of the design control process as well as completing FMEA and Risk analysis
  • Create Solidworks models and technical drawing files in accordance with company drafting standards as applicable
  • Serving as the Senior Tools and Templates expert consultant and Biomedical Engineer for the Office of Device Evaluation (ODE)
3

Responsibilities For Supervisory Biomedical Engineer Resume

  • Monitor published hazard reports and device warnings and for investigating any device related incident occurring in the facility
  • Proficient in electrical circuit design, soldering, and digital signal processing with MATLAB software
  • TEMA 2D, 3D and 6DOF video tracking software to conduct post-test high speed video processing and analysis
  • Be open to learning new technologies, and implementing where necessary
  • Knowledge of the most complex and specialized clinical technology including service, system administration, training, and quality assurance
  • 2) Knowledge of the most complex and specialized clinical technology including service, system administration, training, and quality assurance
  • Initiate and author design of experiments for process or prototype development and testing
  • Support regulatory submissions through testing and data collection
4

Responsibilities For R&d-advanced Biomedical Engineer, Surfaces Resume

  • Perform and coordinate product testing of allografts, biologics, and medical devices, based on design requirements
  • Lead general R&D initiatives and process improvement activities to support new product development and manufacturing
  • Analyze and report data as appropriate to support R&D project management reporting and activities
  • Knowledge of a wide range of biomedical engineering concepts, principles, and methods
  • Knowledge of sciences related to biomedical engineering
  • Communicate in Writing?
5

Responsibilities For Biomedical Engineer Clinical Resume

  • BS in biomedical engineering or related discipline
  • Familiarity with scalable bioproduction concepts and methodologies including bioreactors, microcarriers, and/or adult stem cells
  • Knowledgeable in calibration, medical instrument maintenance and safety procedures applied in a laboratory setting
  • Biomechanical investigations and/or testing
  • High Speed Video system cameras, lighting, and lens selection, to include pre-test production and post-test analysis
  • Be able to accomplish engineering tasks on your own, without much guidance
  • Formal training in PACs systems required
6

Responsibilities For Biomedical Engineer Apprentice Resume

  • Knowledge of, and ability to apply, the principles, theories, concepts, and practices of the engineering profession
  • Knowledge of, and ability to interpret and apply, relevant codes, regulations, guidelines, and standards associated with engineering
  • Keep abreast of changes in technology and to utilize information gained in the solution of engineering problems
  • Prepare written and graphic presentations for other technical staff including technicians and other junior engineers
  • Knowledge of the principles, theories, concepts, and practices of the biomedical engineering profession
7

Responsibilities For Biomedical Engineer Intern Resume

  • Knowledge of organizational concepts and an understanding of the operational needs of other administrative hospital services
  • Maintains laboratory equipment and ensures that it is in operating condition
  • Familiarity with medical device compliance and regulatory requirements (such as IEC 60601) into product design desired
  • Maintain detailed records of each case in accordance with the company’s Quality Management System
  • Innovate and contribute to Canon’s intellectual property portfolio
  • Serves as a member or advisor to the hospital’s Environment of Care (EOC) and Risk Management
  • Perform initial inspection of 3D printed surgical splints for voids, flaws, or other inaccuracies
  • Use hand tools to buff, clean, or modify the surgical splints as needed
  • Gather materials, paperwork, and parts for the final inspection process
8

Responsibilities For Junior Biomedical Engineer Resume

  • Observes procedural cases in hospitals
  • Works closely with other medical professionals, such as doctors, PAs and nurses to understand customer needs
  • Conducts literal research to stay abreast in field
  • Design systems and products, such as artificial devices that replace or enhance the human body, and machines for diagnosing medical problems to include monitoring devices and artificial intelligence diagnostic assistance tools
  • Install, adjust, maintain, repair, or provide technical support for biomedical equipment
  • Train clinicians and other personnel on the proper use of equipment
  • Assist with proposal development and white paper generation related to biomedical engineered solutions
9

Responsibilities For R&d-senior Biomedical Engineer Resume

  • Planning and experimental execution; oversee and progress multiple high priority projects concurrently, manage international relationships and collaborative PD efforts
  • Interface effectively with both highly technical and non-technical partners
  • Reduce time to market and/or protect timeline to product launch by providing strategic test plans to ensure appropriate data is available for regulatory submissions and sales and marketing collateral
  • Perform competitive product evaluations and report results to liaisons in sales and marketing as appropriate
  • Create comprehensive test plans, analyses and technical summaries; execute plans and supervise activities and personnel as required
  • Utilize basic and advanced statistical and data analysis methods (e.g., Minitab®, MS Excel)
  • Adhere to all safety policy procedures
10

Responsibilities For Biomedical Engineer Ct / mr Resume

  • Review individual complaints and associated service data to determine risk level and complete investigation into the 'As Determined' problem and cause coding for each complaint
  • Analyze data from various quality inputs (including but not limited to: nonconformance, FCA, complaints, MDR, etc) to determine trends and systemic issues. Prepare and issue reports based on information analysis
  • Medical device experience
  • Experience with any statistical software package, Minitab
  • Support CAPA and maintenance activities for existing product lines
  • Recommend, and/or support projects for improvements to the quality system as approved by management

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