Senior Engineer, R&D Verification and Validation Specialist

7 hours ago

Andover, Massachusetts, United States Omni Inclusive Full time
Job Summary

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. The successful candidate will be responsible for executing design verification and validation testing, ensuring compliance with regulatory requirements and quality standards.

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 and technical reports.
  • 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, operations, quality, and IT teams.
  • Support data review, analysis, and interpretation, and identify out-of-specification results.
Requirements
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related field.
  • 5+ years of experience in medical device, pharmaceutical, or life sciences field.
  • Practical experience with NPD process, design lifecycle phases, and product design qualification.
  • Experience with authoring design verification test plans and protocols.
  • Experience with executing design verification and validation on electromechanical medical devices.
  • Demonstrable proficiency in statistical data analysis methods and tools.
  • Working knowledge of medical device regulatory standards, including FDA 21CFR 820 and ISO 13485.
Desired Qualifications
  • 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.
  • Drug delivery or combination medical device development experience.
Knowledge, Skills, and Abilities
  • 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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