New Product Development Engineer

• Act as the manufacturing engineering representative on new product development and sustaining project teams.
• Lead and influence D esign for Manufacturability (DFM) and Design for Assembly (DFA) activities throughout the design lifecycle.
• Review and provide formal manufacturing input on product designs, drawings, specifications, and change orders.
• Ensure all manufacturing-related deliverables are completed accurately, on time, and in alignment with project timelines.
• Define and document manufacturing processes, equipment requirements, tooling, fixtures, and work instructions for new products.
• Support and/or lead process validation activities (IQ/OQ/PQ) in collaboration with Quality Engineering.
• Partner with Quality to ensure compliance with FDA, ISO, and internal Quality System requirement s during product development and transfer.
• Identify manufacturing risks early and drive mitigation plans to support robust product launches.
• Support pilot builds, first article builds, and production ramp up activities.
• Collaborate with Supply Chain to support supplier selection, supplier readiness, and manufacturability of purchased components.
• Provide technical support during design reviews, risk assessments (e.g., PFMEA), and change management activities.
• Contribute to continuous improvement initiatives related to manufacturing efficiency, quality, and cost.
• Maintain accurate documentation in accordance with document control and change management procedures.

Knowledge and Expertise

• Bachelor’s degree in Engineering (Manufacturing, Mechanical, Biomedical, Industrial, or related field) required
• Experience in manufacturing engineering within a regulated environment (medical device, aerospace, automotive, or similar).
• Experience supporting new product development and product transfer to manufacturing.
• Demonstrated experience applying DFM/DFA principles to product designs.
• Strong understanding of manufacturing processes, tooling, fixtures, and production equipment.