Sr. Manufacturing Engineer - Primary Talent Partners

Job Description:

This position is for a Senior Manufacturing Engineer who will play a crucial role in supporting a lead manufacturing engineer during the development and validation phases of new production lines for a groundbreaking medical device (electronic hardware). The incumbent will be responsible for a wide array of duties, primarily focusing on the following:

Responsibilities:

1. Support the development and validation of new production processes.
2. Manage product Bill of Materials (BOM) configurations in Product Lifecycle Management (PLM) system.
3. Develop and characterize the manufacturing process window, ensuring process capability across all variations in production materials and processes.
4. Plan and execute activities, including statistical analysis, to assess process repeatability through equipment qualification and process validation (Installation Qualification/IQ, Operational Qualification/OQ, Performance Qualification/PQ).
5. Define and generate all necessary documentation to support manufacturing protocols, reports, changes, and instructions, including but not limited to Engineering protocols, reports, Process Failure Mode and Effects Analysis (PFMEA), manufacturing instructions, change orders, and statistical analyses.
6. Provide engineering support to manufacturing operations and resolve quality issues arising on the production floor.

Minimum Requirements:

• Bachelor’s Degree in a technical discipline
• Minimum 4 years of experience required

Nice to Have:

• Master’s Degree in a technical discipline
• Medical Device and/or Manufacturing Experience
• Experience in a medical device manufacturing environment
• Experience in an electronics manufacturing environment
• Knowledge of Electrostatic Discharge (ESD) controls

Must Have:

• Bachelor’s of Engineering degree (Mechanical, Electrical, Software, or Bio-Medical)

Nice To Have:

1. Investigation and root cause analysis skills
2. Technical writing knowledge
3. Organization and Communication skills
4. Process Validation and Computer software validation knowledge
5. Applied knowledge of basic statistics
6. Black Belt Lean Six Sigma certificate
7. Certified Green Belt Certification
8. Certified Lean Six Sigma Black Belt in Engineering
9. Certified Lean Six Sigma Green Belt professional
10. Equipment Installation Qualification
11. ESD manufacturing environment experience
12. Knowledge in PFMEA and Test Method Validation
13. Knowledge of Good Manufacturing Practices (GMP)/Quality System Regulations (QSR)
14. Medical Device Manufacturing Experience