Sr Product Engineer

Sr Product Engineer

Location: Northridge, California

Category: Engineering

Salary: Pay 50-53/h depending on experience

Country: United States

Employment: Contract

Worksite: On-Site

Job Description

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

Requirements

• 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.

Technical skills:

• 5-8+ years of product engineering experience

• Validation experience, design analysis, V&V testing, PLM, Design Controls, ISO 13485, FDA 21 CFR Part 820

• Equal Opportunity Employer

• We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.