Medical Device - Manufacturing Engineer

Principal Engineer

The Principal Engineer, having 20+ years of experience in Manufacturing and NPI, will serve as the technical authority in manufacturing process development and transfer for new medical device products.

This role focuses on ensuring manufacturability, scalability, and efficiency in alignment with quality and regulatory standards.

The incumbent will lead cross-functional initiatives to bring innovative products from development to production while driving process excellence and operational readiness.

Medical devices technical transfer

Supporting medical device manufacturing

Develop and validate robust manufacturing processes for new product introductions.

Collaborate with design engineering teams to ensure designs are manufacturable and cost-efficient.

Manage the transition of products from development to production, ensuring readiness of equipment, tooling, and processes.

Partner with supply chain teams to qualify and onboard suppliers.

Establish and oversee pilot production runs to ensure process capability and stability.

Lead the creation of process flow diagrams (PFDs), control plans, and work instructions for new product lines.

Process characterization, equipment IQ/OQ, process OQ, and PQ

Test method Validation, Gage R&R

Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers.

Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc.

Conducting feasibility study to estimate a product cost and analyze capital equipment, capacity, and capability requirements

Establishing and improving process methods that meet performance and quality requirements

Developing and executing project plans and schedules for work activities

Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.

Evaluating multiple options to select the most appropriate processes and machining methods