Role: Quality Engineer - Implantable Medical Devices
Location: San Francisco, CA - Onsite
Duration: 12+ months on W2/1099
We are seeking an experienced Quality Engineer to support our client in the development and commercialization of cutting-edge implantable medical and connected health technologies. The ideal candidate will bring hands-on experience in medical electromechanical devices (such as pacemakers, heart pumps, artificial hearts, or infusion pumps), and a proven track record of operating effectively in startup or small company environments.
Key Responsibilities:
- Serve as a hands-on Quality Engineering expert supporting product development and sustaining activities.
- Ensure compliance with medical device regulations and standards (e.g., ISO 13485, ISO 14971, IEC 60601, IEC 62304).
- Apply statistical process control and risk management principles to drive product and process quality.
- Collaborate across cross-functional teams (Engineering, R&D, Manufacturing, Software) to ensure design and process controls are effectively implemented.
- Contribute to and/or lead internal audits; support external audits as needed.
- Provide input and support during design reviews and verification/validation activities.
Required Qualifications:
- 5-10 years of quality engineering experience in the medical device industry.
- Strong background in active implantable medical devices - such as pacemakers, orthopedic implants, heart pumps, or other electromechanical devices.
- Experience working in startup or small company environments with the ability to "wear multiple hats".
- Working knowledge of micro-electro-mechanical systems (MEMS) is highly preferred.
- Experience with electrical safety standards (IEC 60601) and software development lifecycle (IEC 62304).
- Familiarity with cloud-connected health applications and data integrity principles.
- Proficient in risk management processes (ISO 14971) and statistical process control (SPC).
- Auditing experience is a strong plus.
Preferred Traits:
- Self-starter with a strong sense of ownership and ability to operate independently.
- Comfortable working in dynamic, fast-paced environments with limited structure.
- Strong problem-solving, analytical, and communication skills.