Sr. Staff Engineer, Mechanical
Job Location:
San Jose, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Job Description
Job Title: | Sr. Staff Engineer Mechanical |
Reporting to: | Director Engineering |
Location: | San Jose California |
Job Site: | On-Site |
Job Description Revision Date: | July 2026 |
About us:
We know what it takes to be a key partner in life science and medical industries. Since 2002 Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments software and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 is a growing company with offices in San Jose and Carlsbad CA Wilmington MA Indianapolis IN and Costa Rica.
We are seeking a results-driven individual to join our growing organization in San Jose California facility.
Job Summary:
In this role you will have the opportunity to work on the platform engineering mechanical team in San Jose CA. This role involves working on current and next-generation mechanical designs of medical instruments. You will be part of a dedicated team working in a dynamic environment. Open communication empowerment innovation teamwork and customer success are the foundations of the team. As Sr. Staff Mechanical Engineer in Medical Devices you are a principal-level technical leader responsible for designing life-saving products. You must balance cutting-edge mechanical engineering with strict regulatory compliance to ensure patient safety.
Key Responsibilities:
- Product Architecture: Lead the design and engineering of complex medical hardware such as surgical robots implantable devices or diagnostic equipment.
- Regulatory Compliance: Author technical documentation for FDA submissions (510k PMA) and international bodies strictly following FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
- Risk Management: Lead formal Risk Assessments including Design Failure Mode and Effects Analysis (DFMEA) to meet ISO 14971 standards.
- Design Verification & Validation (V&V): Formulate comprehensive V&V protocols build test fixtures and execute rigorous testing to prove safety and efficacy.
- Cross-Functional Leadership: Partner closely with Quality Assurance Regulatory Affairs Clinical Teams and external Contract Manufacturers (CMs)
Qualifications & Requirements:
- Education: Bachelors Masters or Ph.D. in Mechanical Engineering or Biomedical Engineering.
- Experience: Usually 10 years in a highly regulated industry with a proven track record of launching commercial medical products.
- Technical Skills: Mastery of GD&T tolerance stack-up analysis and finite element analysis (FEA) for biocompatible materials.
- Manufacturing Knowledge: Expertise in specialized processes like plastic injection molding precision machining ultra-sonic welding and cleanroom assembly.
- AI & Connected Devices: Increasingly roles require awareness of software integration tracking FDA guidelines on AI-enabled medical devices to ensure system-level safety.
CompanyBenefits:
Health Dental and Vision insurance; 401(k); Life insurance; STD LTD; Flexible spending account Health savings account; Paid time off; Paid Holidays Bereavement and Jury Duty paid time off Employee discounts Referral program.
Message to applicants:
The salary range posted for this position reflects the projected hiring range for new hire full-time salaries in U.S. locations not including benefits. For non-sales roles the hiring ranges reflect base salary only. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors including but not limited to skillset experience and relevant education certifications or training. Applicants may not be eligible for the full salary range based on their U.S. hiring location.
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Required Experience:
Staff IC
About Company
Gener8 provides end-to-end guidance and engineering solutions to help innovators commercialize their product development ideas.
