NPI Engineer- Hardware Test

W2 Employment Opportunity
- Unable to Offer Sponsorship

Medical Device
- New Product Introduction Engineer, Hardware Test

Location: San Jose, CA

Duration: Multiyear Project

Vacation Time: 13 days of PTO + 9 paid holidays

Role Offers: health, dental, vision benefits & 401K enrollment options

The team is in the final stages of pre-launch for an innovative medical device. This role is critical to ensuring product quality, patient safety, and regulatory compliance. Targeting experience in automated testing using Python, strong problem‑solving skills, and familiarity with regulated environments (FDA, ISO 13485, IEC 62304).

• Design and maintain test procedures, TMPs, TMVs, and TPI documentation
• Support agile release cycles, ensuring testing readiness and quality gates are met
• Participate in verification and validation (V&V) activities to ensure system readiness for launch
• Develop test protocols and reports aligned with regulatory standards
• Modify and edit existing Python test scripts
• Perform functional, integration, system, and regression testing
• Automate test data generation, execution pipelines, and result validation
• Maintain traceability between requirements, test cases, and defects

• 1-3 years of experience
• Mechanical Engineering background
• Ability to modify and edit test scripts – Python
• Preferred: medical device, electromechanical or complex capital equipment experience

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.