Senior Engineer, R&D Verification and Validation Specialist
1 week ago
We are seeking a highly skilled Senior Engineer to lead our R&D Verification and Validation team in the development of complex electromechanical medical devices. As a key member of our team, you will be responsible for executing design verification and validation testing to ensure the quality and safety of our products.
Key Responsibilities- Develop and optimize physical test methods and test fixtures to support design verification and validation
- Lead and execute test method validation, design verification, and test method transfer
- Author design verification protocols to satisfy product design inputs and regulatory requirements
- Manage and track product configurations through design verification and validation
- Perform hands-on and simulated testing for design verification and test method developments
- Conduct functional and performance testing to ensure product specifications are met
- Collaborate with external development partners and equipment suppliers to achieve design verification and validation deliverables
- Support data review, analysis, and interpretation, and identify and report out-of-specification results
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related field
- 5+ years of professional experience in the medical device or pharmaceutical industry
- Practical experience with the New Product Development process, including design lifecycle phases and product design qualification
- Experience with authoring Design Verification test plans and protocols
- Experience with executing Design Verification and/or Design Validation on electromechanical medical devices
- Graduate degree in Engineering or related field
- 8+ years of post-educational experience in Medical Device Design
- Six Sigma certification training or experience
- Prior experience with executing mechanical safety testing and working with external test houses
- Leadership and team building skills
- Disciplined and well-organized
- Ability to manage competing priorities effectively
- Clear communication skills
- Deep understanding of establishing project and product requirements
- Collaborative and results-driven
Omni Inclusive is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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Andover, Massachusetts, United States Omni Inclusive Full timeJob SummaryWe are seeking a highly skilled Senior Engineer, R&D Verification and Validation, to join our team. As a key member of our R&D team, you will be responsible for the execution of design verification or design validation testing in support of new product development for complex electromechanical medical devices.Key ResponsibilitiesDevelops new or...
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Senior Engineer, R&D Verification and Validation
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Andover, Massachusetts, United States Omni Inclusive Full timeJob SummaryWe are seeking a highly skilled Senior Engineer, R&D Verification and Validation, to join our team at Omni Inclusive. As a key member of our R&D team, you will be responsible for the execution of design verification or design validation testing in support of new product development for complex electromechanical medical devices.Key...
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Andover, Massachusetts, United States Omni Inclusive Full timeJob SummaryWe are seeking a highly skilled Senior Engineer to lead our R&D Verification and Validation team in the development of complex electromechanical medical devices. The successful candidate will be responsible for executing design verification and validation testing, ensuring compliance with regulatory requirements and quality standards.Key...
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