Manufacturing Engineer
On-site · Whitestown, Indiana, United States
Job Summary
Manufacturing Engineer (staff level) responsible for leading electro-mechanical prototype development, equipment repairs and upgrades, design verification, root cause analysis, and testing for compliance with medical device design standards. Works across mechanical, electronic, optical, and software-controlled systems to support design, verification, validation, and manufacturing processes. Generates formal reports and presentations to support Quality System and business needs, interacts with Manufacturing, Engineering, Quality, and R&D, andInteracts with outside vendors. Willingness to travel to supplier/PTS sites as needed. Responsible for documenting specifications, test results, and operating instructions, and participating in Factory Acceptance / Site Acceptance testing.
Required Qualifications
- Bachelor’s degree (B.S.) in Mechanical Engineering or related Engineering discipline
- Minimum of five (5) years hands-on related experience in a design, development, and manufacturing environment
- Working knowledge of the medical diagnostics / medical device industry
- Experience with equipment/process validation
- Experience using risk mitigation tools such as PFMEA and Control Plans
- Strong mechanical aptitude; hands-on capability for troubleshooting and repairs
- Working with analytical software will be required
- Detailed, meticulous application of engineering principles
- Able to provide leadership or mentorship among team members; provides support and encourages collaboration
- Experience with automated assembly lines preferred
- Willingness to travel to supplier / PTS sites as needed
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