Required Skills:- 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.
Role Description:- 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
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Syntricate Technologies Inc