R&D Test Engineer

Getinge•Fraser, MI

1d•$90,000 - $105,000

About The Position

The R&D Test Engineer is responsible for being the lead in development of test methodology and test plan development supporting the verification and validation testing for medical devices, including improvements. This position will also support the authoring and execution of test protocols. This position is an individual contributor role.

Requirements

Meet the qualifications of the job through education, training, or prior experience
Experience with current industry practices for performing and documenting verification
Ability to communicate within the discipline and with others who are perhaps not as technically trained
Ability to work collaboratively with others and share deliverable responsibilities among the team
Work in an organized, methodical manner
Excellent written and oral communication skills
Adequate computer skills (Microsoft Office Suite)
Able to take precise measurements
Able to solve problems
Able to troubleshoot
Able to analyze & interpret data
Bachelor’s degree in R&D or Engineering preferred
3-5 years’ experience in R&D or related field
Use of computer and telephone equipment and other related office accessories/devices to complete assignments
Able to lift to 15 lbs.
Ability and willingness to travel to outside test labs to execute/support any offsite lab testing activities
Wear face masks and PPE wherever required.

Responsibilities

Translate Design Requirements into Design Verification and Validation (V&V) Testing
Own Test Method Validation (TMV) for novel testing approaches
Design test setup and methodology for product testing
Own novel complex protocol development
Lead test failure investigations and document deviations
Chair cross-functional reviews for protocols, test reports, and deviations
Research different test methods and standards
Advise and support improvements to verification and validation SOPs and tools
Write work instructions, protocols, reports
Perform other product development and laboratory tasks on an as-needed basis
Build Quality into all aspects of their work by maintaining compliance with all quality requirements.
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
Attend all required Quality & Compliance training at the specified interval.
Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
Integrate environmental considerations into all aspects of work and maintaining compliance to all environmental, health, and safety requirements
Ensure review of all processes and activities for potential environmental improvements and implement necessary changes as applicable to the job function.
Must have general understanding, at a minimum, of Getinge Environmental Policy.
Consider environmental legislation and regulations as a minimum requirement