Sr. Staff Engineer, Mechanical

Gener8, LLC•San Jose, CA

4d•$144,773 - $193,031•Onsite

About The Position

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.

Requirements

Bachelor's, Master's, or Ph.D. in Mechanical Engineering or Biomedical Engineering.
Usually 10+ years in a highly regulated industry, with a proven track record of launching commercial medical products.
Mastery of GD&T, tolerance stack-up analysis, and finite element analysis (FEA) for biocompatible materials.
Expertise in specialized processes like plastic injection molding, precision machining, ultra-sonic welding, and cleanroom assembly.
Increasingly, roles require awareness of software integration, tracking FDA guidelines on AI-enabled medical devices to ensure system-level safety.

Responsibilities

Lead the design and engineering of complex medical hardware, such as surgical robots, implantable devices, or diagnostic equipment.
Author technical documentation for FDA submissions (510k, PMA) and international bodies, strictly following FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
Lead formal Risk Assessments, including Design Failure Mode and Effects Analysis (DFMEA) to meet ISO 14971 standards.
Formulate comprehensive V&V protocols, build test fixtures, and execute rigorous testing to prove safety and efficacy.
Partner closely with Quality Assurance, Regulatory Affairs, Clinical Teams, and external Contract Manufacturers (CMs)