Job Description

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.

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