Sr. Engineer, R&D Testing

Getinge•Fraser, MI

6d•$99,680 - $125,000•Onsite

About The Position

The Sr. 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 be responsible for the authoring and execution of test protocols and provides skilled technical insight to enable final product design by building final product test plans and providing final analysis aligned with global product qualification requirements. 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
Excellent 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, Engineering, or similar technical discipline required
Minimum of 5 years of experience testing and validating new products in R&D or related field
Excellent mechanical/chemical aptitude or skill such as working knowledge of cleaning verification devices, or similar, to troubleshoot, repair, and calibrate equipment
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.

Responsibilities

Responsible for completing all R&D protocol generation, assisting with test execution, and protocol reporting, including event reporting.
Lead and complete Design Verification and Validation test planning, execution, interpretation, and reporting.
Own Test Method Validation (TMV) for novel testing approaches
Apply scientific and technical test acumen toward the development of new test methodologies and improvement of existing methodologies, as well as execution of test method validations.
Own novel complex protocol development
Lead test failure investigations and document deviations
Coach laboratory personnel as required
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
Perform other product development and laboratory tasks on an as-needed basis