Sr. Staff Engineer, Mechanical

Gener8,-LLC; Wilmington (MA); On-site; USD 145,000 - 193,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Life insurance

STD/LTD

HSA/FSA

Paid time off

Holidays and jury duty PTO

Employee discounts

Referral program

Job summary

Gener8, LLC in San Jose, CA is seeking a Sr. Staff Mechanical Engineer (Staff Lead) to drive the design of medical instruments and life‑saving devices on an on-site basis.

You will balance advanced mechanical engineering with regulatory compliance, lead DFMEA/V&V activities, and collaborate across QA, regulatory, and manufacturing teams to deliver safe, effective products.

Qualifications

• Bachelor’s, Master’s, or Ph.D. in Mechanical or Biomedical Engineering.
• 10+ years in a highly regulated medical devices industry.
• Expertise in GD&T, tolerance stack-up, and FEA for biocompatible materials.
• Experience with plastic injection molding, precision machining, ultrasonic welding, and cleanroom assembly.

Responsibilities

• Lead design of complex medical hardware and surgical devices.
• Author FDA submissions (510k, PMA) and ensure ISO 13485 compliance.
• Drive DFMEA and risk management to meet ISO 14971.
• Develop V&V protocols and test fixtures for safety and efficacy.
• Collaborate with QA, Regulatory Affairs, Clinical teams and CM partners.

Skills

GD&T

Tolerance analysis

FEA

Biocompatible materials

Plastic injection molding

Precision machining

Ultrasonic welding

Cleanroom assembly

AI in medical devices

Regulatory awareness

Education

Mechanical or Biomedical Engineering (Bachelor's/Master's/PhD)

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Gener8, LLC, Wilmington, MA, US

Salary Range: $144,773.00 To $193,030.50 Annually

Job Description

Job Title:

Sr. Staff Engineer, Mechanical (Staff Lead)

Reporting to:

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: Bachelor's, Master's, 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.

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 candidate's 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.

• Gener8 values diversity in our workplace. Our company provides equal opportunity for employment to qualified applicants based on experience and the ability to do the available work, without regard to race, religion, color, age, sex/gender, sexual orientation, national origin, gender identity, disability, marital status, veteran status, genetic information, ancestry, or any other status protected by law. We are committed to compliance with all fair employment practices regarding citizenship and immigration status.
• We are an Everify Employer. Due to the nature of our projects, you must be a US Permanent Resident or a US Citizen for consideration.