Position title
R&D Engineer (Medical Device Design)-San Diego

Our client is a company that is focused in the medical device industry, and they are hiring a Project Engineer with 4-8 years of experience. The person hired will be a salaried employee who will work full cycle product development and post-market surveillance activities, and be working on a wide range of projects simultaneously.  The person hired into this role will have a solid background in product design, including 2D/3D CAD design and Geometric Dimensioning and Tolerancing (GD&T) experience.  This person will be responsible for overseeing the manufacturing of design prototypes and production parts, working directly with clients and internal team members to meet deliverables.

This position is a full time, salaried role with full corporate benefits.

This is a small team of tenured Engineers and Regulatory Affairs SMEs who work closely together. This is an environment that fosters professional development, engineering excellence and a creative approach to the industry’s toughest product design and quality challenges.

Are you an Engineer looking to utilize a breadth of skills and knowledge, working with a variety of technologies without having to change jobs, or be siloed in one area?

Do you enjoy a small, family-like environment where people help each other be their best? (and offers a chance to work remotely)?

If so, this is the opportunity for you! Apply now to learn more about how you can catapult your career in the industry!

• Interface with quality, operations, and vendors to ensure manufactured products meet design intent
• Create and maintain device history files per FDA, ISO and other regulations
• Assist with development and/or revision of Quality System procedures and processes.
• Assist with internal and supplier audit development, implementation, and execution
• Serve as a company representative during external audits by Regulatory and Third Party Auditors
• Design Control documentation assistance
• Validation and Testing Protocol Development
• Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements

• Bachelor’s Degree in Engineering, Science, or health-related field
• 2-10 years’ related work experience in the medical device industry

Experience Required:
• Working knowledge of FDA and other regulatory authorities with experience supporting compliance.
• Quality Systems development, implementation, and training experience
Experience with ISO 13485, FDA, MDR (Medical Device Regulation), and CMDR (Canadian Medical Devices Regulations) compliance requirements and training
• Experience with Risk Management per ISO 14971
• Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls

Employment Type
Medical Device
Job Location
San Diego, CA
Remote work possible
Date posted
March 8, 2023
PDF Export
Close modal window

Thank you for submitting your application. We will contact you shortly!