San Francisco Bay Area, CA
Senior Manufacturing Engineer (or Manager)
Design and develop manufacturing processes, tooling, and fixtures in order to meet daily
production schedules while enhancing productivity and product quality.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
• Responsible for all aspects of combination product manufacturing engineering.
• This will include new product transfers, prototype fabrication, process development and process validations.
• Design and build or acquire production equipment and tooling.
• Oversee the manufacturing lines; coordinate manufacturing workflow.
• Includes writing test plans, protocols and reports in conjunction with verification and
• validation testing, and equipment qualification (IQ/Operational Qualification/Process
• Performance Qualification).
• Optimize manufacturing processes and production lines to increase efficiencies and yields in manufacturing.
• Provide manufacturing engineering support to new product development projects.
• Train & supervise manufacturing assemblers as required.
• Oversee outside vendors and supplier as necessary.
• Establish and maintain a QSR-compliant manufacturing environment.
• Ensure compliance with all ISO, EN, MDD and FDA regulations and requirements pertaining to manufacturing engineering.
• Participate in the development of FMEA and other risk assessment documentation.
QUALIFICATIONS (EDUCATION, EXPERIENCE, SKILLS):
• BS in Mechanical or Manufacturing Engineering required.
• 10+ years experience in the medical device manufacturing field (Class III device and catheter experience required).
• Strong written and verbal communication skills, including good interpersonal skill.
• Proficient with Microsoft Office applications and CAD software (SolidWorks preferred).
• Hands-on attitude with proven track record for efficiently resolving materials, process, equipment, or training issues on production floor.
• Ability to plan and implement projects from concept to completion.
• Ability to define problems, collect data, establish facts, draw valid conclusions and implement solutions.