Overview

The Senior Manufacturing Engineer will lead advanced manufacturing process development, CNC programming initiatives, and production readiness activities across medical device components and assemblies. This role supports both new product introduction (NPI) and continuous improvement for Class II and III medical devices, including CNC-machined components, catheter sub-assemblies, and finished device manufacturing. The ideal candidate has strong CNC machiningexpertise,deepunderstanding of medical device manufacturing requirements, and proven experience driving process improvements, validations, and cross-functional technical leadership.

Responsibilities

CNC & Process Engineering

• Program new CNC jobs and optimize/modifyexisting CNC programs (Milling, Multi-Axis, and Wire EDM).

• Design and conceptualize fixtures, tooling, and work-holding solutions for repeatable, high-efficiency production.

• Troubleshoot CNC programs, machining processes, equipment issues, and work-holding constraints.

• Apply high-efficiency machining techniques and support machining of exotic/high-temperature alloys.

• Provide runtime, cost, and work-holding estimates for new product quotations.

• Develop clear work instructions, setup sheets, and visualaids;train operators on proper CNC setup and operation.

Manufacturing Process Development & NPI

• Act as Manufacturing Engineering representative on NPI core teams, supporting product launches from early concept through production transfer.

• Manage development and build schedules for new and existing medical device programs,interfacing directly withcustomers and Business Development.

• Design and develop scalable manufacturing processes, tooling, and fixtures that ensure product quality, operator safety, and production efficiency.

• Transfer new processes and product lines from multi-site R&D or prototyping teams to production, ensuring readiness and sustainability.

• Provide hands-on line support: troubleshooting equipment, implementing process improvements, addressing operator inquiries, andoptimizingworkflows.

Quality, Validation & Documentation

• Create andmaintainmanufacturing documentationin accordance withISO 13485 and internal QMS practices.

• Lead process validation activities including IQ/OQ/PQ, TMV studies, equipment commissioning, and preventive maintenance documentation.

• Ensure compliance with customer specifications, FDA requirements, OSHA standards, and applicable regulatory guidelines.

• Prepare detailed engineering reports and effectively communicate results to internal stakeholders and customers.

Continuous Improvement & Technical Leadership

• Identifyand implement improvements that reduce cycle time, lead time, and cost while enhancing yield and product quality.

• Driveutilizationof Lean, Six Sigma, A3, 5-Why, DMAIC, and other structured problem-solving methodologies.

• Lead cross-functional efforts with Engineering, Operations, Quality, Logistics, HR, and external partners to resolve technical challenges.

• Act as a change agent, promoting best practices, disciplined engineering rigor, and data-driven decision making across manufacturing teams.

Required Qualifications

• 5+ years of experience in precision CNC manufacturing.
• Experience in Medical device or regulated environment is preferred.

• Strong background in CNC Milling and Multi-Axis machining including programming, setup, optimization, and troubleshooting.

• Proven CAD/CAM experience (SolidWorks, Mastercam, Esprit, or equivalent).

• Experience machining exotic alloys and performing high-efficiency machining.

• Demonstrated experience designing and developing manufacturing processes, tooling, and fixtures.

• Proficiencyin NPI/PDP processes and transferring products from prototype to production.

• Strong analytical skills including DOE, regression, ANOVA, and process capability analysis.

• Strong written communication skills, withabilityto generate procedures, reports, and validation protocols.

• Experience working within ISO-9001/13485 or similar regulated environment.

• Ability to lead cross-functional teams and manage multiple projects simultaneously in a fast-paced environment.

• Excellent interpersonalskills;able to train operators and collaborate effectively across functions.
• BS or MS in Mechanical, Manufacturing, Biomedical, or related Engineering discipline.

Preferred Qualifications

• MS degree in Engineering or related field.

• Experience in interventional medical device assembly, packaging, or sterilization.

• Experience with Wire EDM, small-hole EDM, and turning systems.

• Lean Six Sigma certification or formal training.

• PMP certification ordemonstratedproject management experience.

• Experience serving as a multi-disciplinecore team lead for NPI medical devices.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Compensation

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $88,000 6 120,000/year.

For temp, temp-to-hire, and regular full-time positions, our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.