Sr Product Engineer
Job in
Northridge, Los Angeles County, California, 91328, USA
Listed on 2026-10-28
Listing for:
Planet Pharma
Full Time
position Listed on 2026-10-28
Job specializations:
-
Engineering
Biomedical Engineer, Quality Engineering, Product Engineer
Job Description & How to Apply Below
Posted:
Location:
Northridge, California Company:
Planet Pharma Group Contact:
Applications Email: applications
Pay 50-53/h depending on experience
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
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