Manufacturing Engineer – NPI

Title:
Senior Manufacturing Engineer – NPI & Validation (Open to Mid-Level & Senior Profiles)

Location: Dayton, OH (Onsite)

Employment Type: Full-Time / Direct Hire

Status: Accepting Candidates

We are supporting a highly regulated manufacturing organization expanding its New Product Introduction (NPI) capabilities for medical device programs. This role plays a critical part in ensuring manufacturing readiness through process validation, equipment qualification, and test method validation (TMV) while remaining hands‑on on the production floor.

This position is well suited for Manufacturing Engineers who enjoy owning validation strategy while actively supporting early production builds and cross‑functional execution.

• Support new product introductions (NPI) for medical device manufacturing programs
• Own and execute process validation strategies aligned with regulatory requirements
• Lead IQ / OQ / PQ activities for manufacturing processes and production equipment
• Drive TMV (Test Method Validation) to ensure product and process readiness
• Partner closely with Quality, Engineering, Manufacturing, and Suppliers
• Provide hands‑on manufacturing floor support during pilot builds and early production
• Ensure validation documentation meets internal quality and regulatory standards

• 1–10 years of Manufacturing Engineering experience (open to strong mid‑level and senior candidates)
• Background in a highly regulated industry such as:
  • Medical Devices
  • Aerospace
  • Automotive
  • Machinery Manufacturing
• Hands‑on experience with process validation and equipment qualification
• Working knowledge of IQ/OQ/PQ and TMV concepts
• Comfortable operating cross‑functionally in fast‑paced NPI environments

Mid‑Senior level

Full-time

Manufacturing and Quality Assurance

Medical Equipment Manufacturing and Manufacturing

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