Senior Product Engineer

Senior Product Engineer

Immediate need for a talented Senior Product Engineer. This is a 12 months contract opportunity with long-term potential and is located in Northridge, CA (Onsite).

Key Requirements and Technology Experience:

• B.S. in Mechanical, Electrical, Biomedical, or related Engineering field
• Bachelor's degree or higher in Life Sciences or related discipline
• Minimum 5-7 years of experience in Quality Assurance and/or Quality Systems within the medical device industry.
• Experience implementing or improving ISO 13485-based QMS.
• Strong experience working with Singapore medical device regulatory requirements.
• Demonstrated experience supporting or leading GDPMDS/GDP certification projects.
• Proven track record of successfully helping organizations obtain and maintain GDP certification
• Experience interacting with certification bodies, accreditation bodies, and regulatory authorities.
• 5-8 years of product engineering experience
• Validation experience, design analysis, V&V testing, PLM, Design Controls, ISO 13485, FDA 21 CFR Part 820
• Product Development & Engineering
• Lead end-to-end product development activities including design, prototyping, testing, and validation
• Drive technical decisions and provide engineering expertise throughout the product lifecycle
• Develop and review engineering specifications, design documents, and technical reports
• Identify and resolve complex engineering challenges using systematic problem-solving approaches
• Cross-Functional Collaboration
• Partner with R&D, Quality, Manufacturing, Marketing, and Regulatory teams to ensure alignment
• Serve as a technical resource and mentor for junior engineers
• Communicate technical concepts clearly to both technical and non-technical stakeholders
• Project Leadership
• Lead or contribute to multiple concurrent engineering projects
• Define project scope, timelines, and deliverables
• Track milestones and proactively manage risks and dependencies Quality & Compliance
• Ensure products meet regulatory requirements (e.g., ISO, FDA, MDR) and internal quality standards
• Support design verification and validation (V&V) activities
• Participate in design reviews, FMEAs, risk assessments, and change control processes
• Continuous Improvement
• Identify opportunities to improve products, processes, and engineering practices
• Apply data-driven methods to analyze performance and drive decisions
• Stay current with industry trends, emerging technologies, and best practices