Sr. Engineer, R&D Testing

Location: Fraser, MI, US Remote Work: 1‑2 days at home (site based) Salary Range: $99,680 - $125,000 annually + 5% bonus target Job Overview The Sr. R&D Test Engineer is responsible for leading the development of test methodology and test plan development supporting the verification and validation testing for medical devices, including improvements. The position authorizes and executes test protocols, provides technical insight to enable final product design by building product test plans and delivering analysis aligned with global product qualification requirements. This is an individual contributor role. Job Responsibilities and Essential Duties 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 developing new test methodologies and improving existing methodologies, and executing test method validations. 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. Required Knowledge, Skills and Abilities 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. Able to take precise measurements, solve problems, troubleshoot, and analyze & interpret data. Bachelor’s degree in R&D, Engineering, or a similar technical discipline required. Minimum of 5 years of experience testing and validating new products in R&D or a related field. Excellent mechanical/chemical aptitude or skill such as working knowledge of cleaning verification devices, or similar, to troubleshoot, repair, and calibrate equipment. 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. Environmental, Safety, and Physical Work Conditions 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 offsite lab testing activities. Wear face masks and PPE wherever required. Integrate environmental considerations into all aspects of work and maintain compliance with environmental, health, and safety requirements. Review processes and activities for potential environmental improvements and implement necessary changes as applicable to the job function. Possess a general understanding, at a minimum, of Getinge Environmental Policy. Consider environmental legislation and regulations as a minimum requirement. May require sitting or standing for long periods of time depending on the project. Benefits at Getinge Health, Dental, and Vision insurance benefits 401k plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Short and Long Term Disability Benefits Health and Dependent Care Flexible Spending Accounts Parental and Caregiver Leave Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process. #J-18808-Ljbffr Getinge