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Norwood Medical · 2 days ago

NPD Process Engineer

Dayton, OH

Contract

Onsite

Mid Level

3+ years exp

Norwood Medical is a contract medical device manufacturer located in Dayton, Ohio, seeking a Process Engineer in New Product Development. This critical role involves developing and implementing manufacturing strategies for new medical components, focusing on translating customer specifications into efficient CNC Machining processes and leading initial production ramp-ups.

Health CareManufacturingMedical

H1B Sponsor Likely

Responsibilities

Lead the development of comprehensive, scalable, and cost-effective manufacturing processes for new medical products, with a primary focus on multi-axis CNC turning and milling

Work closely with customer and internal engineering teams during the design phase to provide feedback on manufacturability, ensuring new products can be produced efficiently and meet required tolerances

Select, justify, and implement necessary equipment, tooling, fixtures, and gaging. Develop and optimize CNC programs, setup sheets, and work instructions for initial production runs

Execute and document process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), in line with FDA/ISO 13485 requirements

Conduct Process Failure Mode and Effects Analysis (PFMEA) to identify and mitigate manufacturing risks associated with new processes

Identify and resolve technical production issues during the initial pilot and validation runs. Drive continuous improvement opportunities in new product processes

Estimate manufacturing costs and cycle times for new products to support quoting and business development activities

Manage assigned new product projects, ensuring milestones are met on time and within budget

Qualification

CNC machining processesCAD/CAM softwareProcess validationGD&TStatistical process controlProblem-solving methodologiesRegulated environment experienceAutomated machine tendingSecondary processes familiarity

Required

Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or a related technical field

Minimum of 3-5 years of experience as a Process, Manufacturing, or CNC Engineer, with significant time spent in a New Product Introduction (NPI) or Development environment

Deep, hands-on knowledge of CNC machining processes (e.g., Swiss-style turning, multi-axis milling, grinding)

Proficiency in CAD/CAM software (e.g., SolidWorks, Mastercam, Esprit) for tooling design and CNC program generation

Strong understanding of GD&T (Geometric Dimensioning and Tolerancing) and metrology

Proven experience working in a regulated environment (ISO 13485, FDA CFR 820) with experience in process validation (IQ/OQ/PQ) and documentation

Proficient in statistical process control (SPC) and problem-solving methodologies (e.g., Six Sigma, 8D)

Preferred

Experience with automated or robotic machine tending systems is preferred

Familiarity with other secondary processes like cleaning, deburring, passivation, or heat treating is preferred

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

Company

Norwood Medical

Norwood Medical is a medical devices company specializing in vacuum heat treating, laser cutting, and surgical devices.

Founded in 1926

Dayton, Ohio, USA

1001-5000 employees

http://norwoodmedical.com

H1B Sponsorship

Norwood Medical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2024 (3)