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.
- 3 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
- Manufacturing engineering background.
- 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.
The IN group is here to support you specifically with the recruitment and hiring process for job opportunities. Our role is focused on guiding you through these steps. If you have any questions related to your application or next steps in the hiring process, Apply, and please feel free to reach out.
