Manufacturing Engineer (All Levels), New Product Development

Key Responsibilities

• Act as the manufacturing engineering representative on new product development and sustaining project teams. 
• Lead and influence Design 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 requirements 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.

Skills Knowledge and Expertise

• Bachelor’s degree in Engineering (Manufacturing, Mechanical, Biomedical, Industrial, or related field) required

• Minimum 1-5 years 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. 
• Working knowledge of quality systems, validation requirements, and regulatory standards (e.g., FDA, ISO). 
• Ability to interpret engineering drawings, specifications, and GD&T. 
• Strong cross functional collaboration and communication skills. 
• Proven ability to manage multiple deliverables and meet project deadlines. 
• Experience with risk management tools such as PFMEA preferred. 
• Proficiency with standard engineering and documentation tools (e.g., CAD viewers, ERP/MRP, document control systems).