Job OverviewThe 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.
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 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
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
- Adequate computer skills (Microsoft Office Suite)
- Able to take precise measurements
- Able to solve problems
- Able to troubleshoot
- Able to analyze & interpret data
Minimum Requirements:- 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
Quality Requirements: 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.
Environmental/Safety/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 any offsite lab testing activities
- Wear face masks and PPE wherever required.
- 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
- May require sitting or standing for long periods of time depending on the project.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Targeted salary range: $99,680- $125,000, depending upon experience and location + 5% bonus target
Benefits at Getinge:At Getinge, we offer a comprehensive benefits package, which includes:
- 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
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
