Job Description

Job Title: Contract Sr. Device Engineer – Combination Products

Location: Foster City, CA (Hybrid/Onsite preferred)

Duration: 12-month contract

Start: December 2025

Overview:

We are seeking a highly experienced Contract Device Engineer to join our Device Development team as a key contributor. This individual will be responsible for authoring and driving critical design control and risk management deliverables throughout the development lifecycle of combination products. The ideal candidate will bring deep subject matter expertise, proactive problem-solving skills, and the ability to execute effectively within evolving business processes.

Key Responsibilities:

• Serve as a subject matter expert in combination product development, providing technical and strategic guidance to the team.
• Author design control and risk management documentation (e.g., design inputs, verification protocols, risk assessments) across all phases of product development.
• Drive deliverables forward to meet program timelines, proactively identifying and resolving issues and bottlenecks.
• Collaborate cross-functionally to ensure consistent interpretation and application of design control principles.
• Execute deliverables while navigating changes to SOPs, templates, and business processes.

Key Requirements:

• 7+ years of experience in medical device or combination product development, with deep expertise in design controls and risk management.
• Demonstrated ability to work independently and execute in complex, dynamic environments.
• Strong communication and collaboration skills; able to influence and support cross-functional teams.
• Expertise in EU MDR compliance and implementation of General Safety and Performance Requirements (GSPR).
• Familiarity with regulatory expectations for combination products and technical documentation.

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