Sustaining Engineer - Medical Devices

Sustaining Engineer - Medical Devices

Global leader in the development and production of life saving medical devices seeks a Sustaining Engineer to lead ongoing engineering projects at the company's flagship site in Orange Co. CA.  The Sustaining Engineer will:

• Act as a project manager for design verification and validation activities of medical device products
• Maintain product performance and quality by leading and assisting with issues relating to CAPAs, complaints and manufacturing support
• Support failure investigation and analysis
• Support CAPA resolution
• Ensure FDA and ISO 13485 compliance
• Support design changes, test method and tooling design
• Develop and drive process enhancement and process improvement

Requirements for Sustaining Engineer:

• Bachelors degree in Mechanical, Chemical, Materials Science, Biomedical Engineering, or related discipline

• 7 + years of engineering experience with Medical Device products including Project Manager experience.

• Strong working experience with design control and design verification activities.

• Strong working experience with engineering principles, scientific analysis, and project management.

• Strong analytical skills and problem solving skills.

• Strong communications skills; oral, written and electronic.

• The ability to prioritize and work simultaneously on competing projects with tight timelines

• The ability to travel up to 50% domestically and internationally
• Experience or the ability to effectively interact with health care professionals

Candidates should submit resumes in WORD format to:  [Click Here to Email Your Resumé]

To see other opportunities go to:  www.appleassocglobal.com