Quality Engineer II - Electronics - Medical Device Manufacturing
Full-Time W2
M- F 8:00 AM- 5:00 PM 40h per week
Location: Alameda California
Benefits: Medical, dental, vision, 401(k), paid holidays, 15+ days PTO, parental leave, disability, and life insurance.
Join a global leader in innovative medical technologies. If you’re passionate about improving patient outcomes and ensuring uncompromising product quality, this role offers the opportunity to make a real impact. Exposure to complex, life-saving electromechanical devices
What you'll do?
Responsible for developing, implementing, and maintaining quality system elements to support both new and existing medical device products.
You will support electronics-heavy, electromechanical Class II & III medical devices, working closely with R&D, Electrical Engineering, and Manufacturing teams. This role centers on design controls, risk management, and hands-on electronics quality support.
This role is on‑site and part of a mission‑driven organization transforming patient care.
Minimum Requirements
- Associate’s or Bachelor’s in Engineering, Life Sciences, or related field.
- 4+ years of experience in quality engineering or similar roles, ideally in medical devices or other regulated industries.
- Electromechanical medical device experience (Class II or III)
- Design Controls experience (hands-on)
- Familiarity with QSR, ISO, and related regulations.
Preferred Experience
- Experience working with electronic devices and PCBAs.
- Strong communication skills—verbal, written, and interpersonal.
- Proficiency with MS Word, Excel, PowerPoint.
- IEC 60601, Risk Management (ISO 14971, FMEA, hazard analysis)
- PCB / PCBA experience
Responsibilities:
Product & Process Quality
- Support qualification and development activities for new and existing electromechanical products.*
- Develop testing and inspection methodologies and documentation.*
- Design QC sampling systems, statistical techniques, and inspection mechanisms.*
- Perform failure analysis and defect investigations. *
- Electromechanical and electronic medical devices
Cross‑Functional Collaboration
- Partner cross-functionally with R&D, Electrical Engineering, and Manufacturing
- Recommend specification revisions and analyze production limitations.*
- Participate in Quality Objective teams.*
Quality Systems & Compliance
- Develop SOPs and facilitate internal audits.*
- Support PCB/PCBA issues (manufacturing, inspection, FA, supplier quality)
- Ensure compliance with IEC 60601 and relevant safety standards
- Participate in failure analysis of electronic assemblies
- Ensure compliance with Quality Management System (QMS) and global regulatory requirements.*
- Promote adherence to security, privacy, and compliance standards.*
- Ensure departmental compliance with QMS, regulations, and standards.*
Other Duties
- Support additional work-related tasks as assigned.
- Possible exposure to blood‑borne pathogens.
- Ability to lift up to 25 lbs and move between buildings/floors.
- Extended periods working on a computer.
