- Posted 16 October 2025
- LocationSan Diego
- Job type Permanent
- Reference224345
Back to jobs
Product and Process Engineer
Job description
Job Summary
We are seeking a highly motivated and detail-oriented Product and Process Engineer to join our dynamic team. The successful candidate will drive the design, development, testing, and production of innovative wound care products to ensure the compliance of regulatory and industry standards. This role requires a strong background in engineering principles, medical device regulations, and a passion for innovation in healthcare technology.
Job description
We are seeking a highly motivated and detail-oriented Product and Process Engineer to join our dynamic team. The successful candidate will drive the design, development, testing, and production of innovative wound care products to ensure the compliance of regulatory and industry standards. This role requires a strong background in engineering principles, medical device regulations, and a passion for innovation in healthcare technology.
Job description
- Create innovative new products and support the enhancement of existing products through sustaining engineering activities.
- Develop and maintain R&D and manufacturing drawings, work instructions, and engineering documentation, ensuring accuracy and organization.
- Troubleshoot and resolve production issues, ensuring smooth manufacturing processes.
- Design and implement fixtures to optimize manufacturing and assembly operations.
- Identify and implement operational improvements to increase efficiency and productivity.
- Maintain detailed records of engineering changes, investigations, and improvements.
- Develop and execute comprehensive testing plans and strategies to validate product performance against requirements and industry standards.
- Organize tasks, establish timelines, and manage projects to ensure timely and successful delivery.
- Provide expert technical assistance to customers, suppliers, and internal teams.
- Support regulatory submission activities, including documentation preparation, testing and other activities
- Work closely with cross-functional teams to drive project success and achieve organizational goals.
- Prepare and present technical reports and presentations for internal and external stakeholders.
- Bachelor’s or advanced degrees in mechanical engineering, biomedical engineering or a related field
- Proficiency in CAD software (e.g. SolidWorks, AutoCAD)
- Minimum of 2 years of experience in medical device or life science industry
- Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products
- Familiarity with medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR).
- Proven ability to contribute to technical and cross-functional teams, driving projects that significantly impact company objectives.
- Strong written and verbal communication skills, with the ability to prepare, present, and discuss project plans, requirements, test results, and other technical information in a team-based environment.