CNC & Process Engineering. Develop new CNC programs and refine existing ones for milling, multi-axis machining, and wire EDM. Design fixtures, tooling, and work-holding solutions to ensure repeatable, high-efficiency production. Diagnose and resolve issues related to CNC programs, machining processes, equipment, and work-holding. Apply high-efficiency machining strategies, including machining of exotic or high-temperature alloys. Provide cost, runtime, and work-holding estimates for new product quotations. Create setup sheets, work instructions, and visual aids; train operators on proper machine setup and operation. Manufacturing Process Development & NPI - Serve as the Manufacturing Engineering representative on NPI teams from concept through production release. Oversee build schedules and development activities for new and existing medical device programs, interfacing with customers and Business Development. Design scalable manufacturing processes, fixtures, and tooling that optimize safety, quality, and efficiency. Transfer new processes from R&D or prototyping environments into full production, ensuring readiness and sustainability. Provide hands-on shop-floor support, troubleshooting equipment, improving workflows, and resolving operator questions. Quality, Validation & Documentation. Create and maintain manufacturing documentation in alignment with ISO 13485 and internal quality system requirements. Lead validation activities including IQ/ OQ/ PQ, TMV studies, equipment qualification, and preventive maintenance documentation. Ensure compliance with customer requirements, FDA regulations, OSHA standards, and other applicable guidelines. Prepare clear engineering reports and present findings to internal teams and customers. Continuous Improvement & Leadership. Identify opportunities to reduce lead time, cycle time, and cost while improving yield and quality. Leverage structured problem-solving tools such as Lean, Six Sigma, A 3, DMAIC, and 5-Why. Lead cross-functional teams to resolve technical challenges across Engineering, Operations, Quality, Logistics, and external partners. Promote engineering rigor, best practices, and data-driven decision-making throughout the organization. . The Successful Applicant 5 years of experience in precision CNC manufacturing. Medical device or regulated manufacturing experience preferred. Strong proficiency in CNC milling and multi-axis machining, including programming, setup, and troubleshooting. CAD/ CAM expertise (Solid. Works, Mastercam, Esprit, or equivalent). Experience machining exotic alloys and applying high-efficiency machining methods. Demonstrated ability to design and develop manufacturing processes, tooling, and fixtures. Experience with NPI/ PDP processes and transitioning products from prototype to production. Strong analytical skills (DOE, regression, ANOVA, process capability). Excellent technical writing skills for procedures, reports, and validation protocols. Experience with ISO 9001/13485 or similar regulated environments. Ability to lead cross-functional teams and manage multiple projects in a fast-paced setting. Strong interpersonal skills; able to train operators and collaborate across groups. BS or MS in Mechanical, Manufacturing, Biomedical, or related engineering field.