Katalyst HealthCares & Life Sciences
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NPI Engineer
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Katalyst CRO . This is a contract position based in Indianapolis, IN, focusing on medical device manufacturing and new product introduction (NPI). Responsibilities
Support medical device manufacturing and develop robust processes for new product introductions. Collaborate with design teams to ensure manufacturability and cost efficiency. Manage product transitions from development to production, ensuring equipment and process readiness. Partner with supply chain to qualify suppliers and oversee pilot production runs. Create process flow diagrams, control plans, and work instructions for new products. Conduct process characterization, equipment IQ/OQ, process OQ, and PQ. Validate test methods, perform Gage R&R, and maintain technical documents. Support various processing applications including machining, forging, casting, and more. Conduct feasibility studies for product costs and capacity analysis. Establish and improve process methods to meet quality standards. Requirements
6+ years in manufacturing and NPI, with expertise in medical device process development and transfer. Strong understanding of manufacturability, scalability, and regulatory standards. Experience leading cross-functional initiatives for product launch. Ability to develop project plans and communicate effectively across teams. Knowledge of process options and machining methods. Familiarity with medical device regulations and NPI processes. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Industry: Pharmaceutical Manufacturing
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NPI Engineer
role at
Katalyst CRO . This is a contract position based in Indianapolis, IN, focusing on medical device manufacturing and new product introduction (NPI). Responsibilities
Support medical device manufacturing and develop robust processes for new product introductions. Collaborate with design teams to ensure manufacturability and cost efficiency. Manage product transitions from development to production, ensuring equipment and process readiness. Partner with supply chain to qualify suppliers and oversee pilot production runs. Create process flow diagrams, control plans, and work instructions for new products. Conduct process characterization, equipment IQ/OQ, process OQ, and PQ. Validate test methods, perform Gage R&R, and maintain technical documents. Support various processing applications including machining, forging, casting, and more. Conduct feasibility studies for product costs and capacity analysis. Establish and improve process methods to meet quality standards. Requirements
6+ years in manufacturing and NPI, with expertise in medical device process development and transfer. Strong understanding of manufacturability, scalability, and regulatory standards. Experience leading cross-functional initiatives for product launch. Ability to develop project plans and communicate effectively across teams. Knowledge of process options and machining methods. Familiarity with medical device regulations and NPI processes. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Industry: Pharmaceutical Manufacturing
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