Job Description

Product Quality Engineer – Pre-Market Medical Devices

Location: San Francisco Bay Area

A fast-growing medical device company focused on pre-market Class II/III products is seeking a Product Quality Engineer to support the development and regulatory approval of innovative medical technologies. This role will play a critical part in ensuring design, development, and risk management activities meet regulatory and quality standards before market approval.

Key Responsibilities:

• Provide quality engineering support throughout the product development lifecycle, ensuring compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Work closely with R&D and Regulatory teams to develop design controls, risk management files, and verification/validation plans.
• Support the creation and execution of design verification and validation (V&V) testing.
• Assist in developing product and process risk assessments (FMEAs).
• Ensure compliance with Good Documentation Practices (GDP) and participate in internal audits and regulatory submissions.
• Collaborate with suppliers and manufacturing partners to establish incoming quality requirements for components and materials.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3+ years of quality engineering experience in the medical device industry, preferably with pre-market products.
• Strong understanding of design control, risk management, and V&V testing.
• Experience with ISO 13485, FDA regulations, and product development processes.
• Knowledge of biocompatibility, sterilization validation, and usability engineering is a plus.

This is an exciting opportunity to be at the forefront of developing innovative medical technologies before they reach the market. If you're passionate about quality engineering in early-stage medical devices, apply today!

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