Senior Product Engineer

Job Description

Job Description

ATR International, Inc. cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar). Candidates must have valid U.S. work authorization.

Please note that neither ATR International nor the client offers relocation assistance for this role; candidates must be local or able to relocate independently.

Senior Product Engineer (12-Month Contract)

Location: Northridge, CA 91325

Job Type: Full-Time / W2 Contract (12 Months)

Pay Rate: $45.00 – $56.43 per hour

Openings: 2

About the Client

Join a world-renowned pioneer in medical technology dedicated to engineering life-changing healthcare solutions. Operating at the forefront of medical device innovation in Northridge, CA, this client delivers cutting-edge technology that directly improves patient outcomes globally. You will work alongside top-tier talent in a collaborative, fast-paced environment where technical expertise, quality, and impactful engineering are celebrated.

Role Summary

We are seeking two qualified Senior Product Engineers to lead end-to-end product development activities across the full engineering lifecycle. In this role, you will drive key technical decisions, manage design verification and validation (V&V), and partner with cross-functional teams to bring high-reliability medical devices to market while maintaining strict regulatory compliance.

Key Responsibilities

• Product Development & Engineering: Lead end-to-end engineering tasks including product design, prototyping, testing, and validation. Author and review detailed engineering specifications, design documents, and technical reports.
• Technical Problem Solving: Resolve complex engineering challenges using systematic, data-driven approaches, risk assessments, and FMEAs.
• Project Leadership: Manage project scope, timelines, milestones, and risk management across multiple concurrent engineering projects.
• Cross-Functional Collaboration: Partner with R&D, Quality, Manufacturing, Marketing, and Regulatory teams to ensure alignment across all project phases.
• Mentorship: Serve as a technical expert and mentor for junior engineering staff.
• Quality & Compliance: Ensure product compliance with ISO 13485, FDA 21 CFR Part 820, and international regulatory standards (e.g., MDR). Direct design controls, design reviews, V&V testing, and change control processes.
• Continuous Improvement: Identify opportunities to optimize product performance, streamline engineering processes, and apply industry best practices.

Requirements & Qualifications

• Education: Bachelor of Science in Mechanical, Electrical, Biomedical Engineering, or a related discipline.
• Experience: 5 to 8+ years of dedicated product engineering experience within the medical device industry.
• Regulatory & Quality Knowledge: Strong expertise in ISO 13485, FDA 21 CFR Part 820, Design Controls, and Quality Management Systems (QMS).
• Technical Proficiency: Hands-on experience with V&V testing, design analysis, and Product Lifecycle Management (PLM) platforms.
• Project & Team Skills: Proven track record leading multi-faceted engineering projects and interfacing with regulatory/compliance bodies

\nCompany Description

ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.

Company Description

ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.