Katalyst Healthcares and Life Sciences
Responsibilities:
- 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.
- The Principal Engineer, having 6 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.
- 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.
- Medical Device & Regulations, New Product Introduction Process (NPI) - Product Engineering.