Manufacturing Process Engineer

Responsible for the following:

• Coordinating and monitoring of all aspects of manufacturing engineering supporting the manufacturing of custom surgical instruments.
• Work with Product Engineering to create manufacturing work instruction and routings
• Confirm manufacturing process and assembly instructions are aligned with engineering and customer requirements
• Performing manufacturing engineering assignments related to both newly developed and legacy surgical instruments
• Supporting the Company's New Product Introduction Team (NPI) to ensure production tooling and equipment readiness with new product introduction schedules.
• Supports sample and low volume production builds
• Developing and implementing specialized manufacturing and assembly tooling and equipment
• Supports the QC Team with the process validation of new manufacturing systems and equipment.
• Optimizing manufacturing processes by implementing Statistical Process Controls, Lean manufacturing, and other related principles.
• Working with Engineer to analyze process data to reduce material scrap and to optimize processes.
• Support the transition of new product introduction from Engineering to the Production Operations Team
• Working with product assurance to ensure all manufacturing processes are documented in accordance with our ISO certifications.
• Optimizing manufacturing systems and tooling use to support the manufacturing of surgical instrumentation.
• Interfacing with outside vendors for manufacturing, measurement and test equipment selection.
• Reading and interpreting technical drawings, product specifications, technical and regulatory requirements, and computer-generated Reports
• Conferring with Company’s Manufacturing Manager, Design Engineering Team and other members of the Engineering and Product Assurance Teams to develop and implement manufacturing processes, procedures and work instructions.
• Resolve manufacturing and production system downtimes, and provide technical information to support corrective actions and improvements.

Skill Requirements:

• Strong verbal and written communication skills
• Strong troubleshooting and evaluation intuitiveness
• Excellent problem solving and time management skills
• Works precisely and pays close attention to details
• Strong mechanical aptitude and knowledge
• Strong Knowledge of LEAN, Six-Sigma, SPC, Shainin, and other process capability and problem solving tools in manufacturing Techniques
• Advanced organizational skills, with the ability to effectively multitask
• Self motivated and highly organized

Technical Requirements:

1. Minimum Education: Bachelor’s Degree in Mechanical Engineering

2. Minimum 5 years prior experience

3. Experience with precision machining and machine tools

4. CAM Programming experience desired – Surfcam, FANUC controller, Abile

5. Knowledge of automated inspection and assembly systems (robotics)

6. Experience with Plastic injection molding and injection molding systems

7. Experience with over molding processes

8. Steel Heat Treat expertise

9. Knowledge of electronic equipment and computer hardware and software, Excel, MS office

10. Background in the Medical Device industry preferred

11. Proficient with Design For Manufacturability (DFM) practices and LEAN Manufacturing principles

12. Familiar with ultrasonic welding of plastic materials

13. Knowledge of material cleaning and passivation processes