Norwood Medical
Job Overview
Norwood Medical is seeking a Process Engineer in New Product Development in Dayton, Ohio, with a contract employment type. The role focuses on translating customer specifications into robust CNC machining processes (multi‑axis turning and milling), ensuring DFM, leading production ramp‑up, and documenting process validation (IQ/OQ/PQ) in accordance with FDA/ISO 13485.
Key Responsibilities
Lead the development of scalable, cost‑effective manufacturing processes for new medical products, with a primary focus on multi‑axis CNC turning and milling.
Collaborate with customers and internal engineering teams during design to provide manufacturability feedback and ensure tolerance compliance.
Select and justify equipment, tooling, fixtures, and gauges; develop CNC programs, set‑up sheets, and work instructions for initial production runs.
Execute and document process validation activities, including IQ/OQ/PQ, per FDA/ISO 13485 requirements.
Conduct PFMEA to identify and mitigate manufacturing risks.
Identify and resolve technical production issues during pilot and validation runs; drive continuous improvement.
Estimate manufacturing costs and cycle times to support quoting and business development.
Manage assigned NPI projects, ensuring milestones are met on time and within budget.
Qualifications
Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or a related field.
3‑5 years of experience as a Process, Manufacturing, or CNC Engineer, mainly in NPI or development.
Hands‑on knowledge of CNC machining (Swiss turning, multi‑axis milling, grinding).
Proficiency in CAD/CAM (SolidWorks, Mastercam, Esprit) for tooling design and CNC programming.
Strong understanding of GD&T and metrology.
Experience in a regulated environment (ISO 13485, FDA CFR 820) with process validation and documentation.
Proficiency in SPC and problem‑solving methodologies (Six Sigma, 8D).
Preferred: experience with automated or robotic machine‑tending systems; familiarity with secondary processes such as cleaning, deburring, passivation, or heat‑treating.
About the Company Located in Dayton, Ohio, Norwood Medical is a contract medical device manufacturer supporting customers in robotic‑assisted surgeries, orthopedics, and minimally invasive surgery markets. We focus exclusively on medical device manufacturing and are dedicated to quality and cutting‑edge technology.
Benefits
Paid time off and holidays.
Medical, dental, vision, and employer‑paid life insurance.
401(k) match.
Climate‑controlled environment.
Career advancement training and opportunities.
Additional Information Referrals increase your chances of interviewing at Norwood Medical by 2x.
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Key Responsibilities
Lead the development of scalable, cost‑effective manufacturing processes for new medical products, with a primary focus on multi‑axis CNC turning and milling.
Collaborate with customers and internal engineering teams during design to provide manufacturability feedback and ensure tolerance compliance.
Select and justify equipment, tooling, fixtures, and gauges; develop CNC programs, set‑up sheets, and work instructions for initial production runs.
Execute and document process validation activities, including IQ/OQ/PQ, per FDA/ISO 13485 requirements.
Conduct PFMEA to identify and mitigate manufacturing risks.
Identify and resolve technical production issues during pilot and validation runs; drive continuous improvement.
Estimate manufacturing costs and cycle times to support quoting and business development.
Manage assigned NPI projects, ensuring milestones are met on time and within budget.
Qualifications
Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or a related field.
3‑5 years of experience as a Process, Manufacturing, or CNC Engineer, mainly in NPI or development.
Hands‑on knowledge of CNC machining (Swiss turning, multi‑axis milling, grinding).
Proficiency in CAD/CAM (SolidWorks, Mastercam, Esprit) for tooling design and CNC programming.
Strong understanding of GD&T and metrology.
Experience in a regulated environment (ISO 13485, FDA CFR 820) with process validation and documentation.
Proficiency in SPC and problem‑solving methodologies (Six Sigma, 8D).
Preferred: experience with automated or robotic machine‑tending systems; familiarity with secondary processes such as cleaning, deburring, passivation, or heat‑treating.
About the Company Located in Dayton, Ohio, Norwood Medical is a contract medical device manufacturer supporting customers in robotic‑assisted surgeries, orthopedics, and minimally invasive surgery markets. We focus exclusively on medical device manufacturing and are dedicated to quality and cutting‑edge technology.
Benefits
Paid time off and holidays.
Medical, dental, vision, and employer‑paid life insurance.
401(k) match.
Climate‑controlled environment.
Career advancement training and opportunities.
Additional Information Referrals increase your chances of interviewing at Norwood Medical by 2x.
#J-18808-Ljbffr