JOB SUMMARY

Lead, coach, and grow high-performing manufacturing engineering and model shop teams. In this role, you will bridge technical strategy and hands-on execution, overseeing design for excellence reviews (DFX) and design transfer to production. You will hold end-to-end accountability for the development, control, implementation, and improvement of production CNC machining and assembly processes. Operating within a regulated medical device environment, you will drive operational excellence to enhance quality, throughput, and process capability. You will serve as a key collaborative leader, partnering closely with cross-functional teams, including quality, manufacturing, R D, supply chain, and regulatory, to foster continuous improvement and ensure seamless production lifecycles.

JOB DUTIES

• Lead, mentor, and scale a high-performing team of manufacturing engineers and model shop technicians by fostering continuous learning, technical excellence, and cross-functional accountability.
• Manage resource allocation, project priorities, and project execution within the team that balances support of immediate and long-term production and business needs.
• Drive DFX (i.e. design for manufacturability, assembly, inspection) reviews during early-stage R D to ensure products are optimized for CNC machining and assembly.
• Establish and maintain manufacturing process documentation via the change control process, including process definition, routing steps, routers, process control documentation, work instructions, and setup sheets.
• Develop clear, repeatable, and controlled manufacturing processes for CNC precision machined components, secondary processes (e.g. heat treatment, deburring, glass bead blast, anodization, etc.), and electro-mechanical assemblies
• Ensure manufacturing processes and documentation accurately translate engineering requirements and manage process risks via process failure modes and effects analysis (PFMEA) (e.g., process flows, control plans, tooling, fixturing, materials, inspection requirements, safety requirements, and quality expectations).
• Establish methods to identify and prioritize continuous improvement initiatives, such as measurement and analysis of productivity, labor efficiency, capacity, cycle time, and throughput, identification of non-value-added activity, process variation, bottlenecks, rework loops, layout inefficiencies, and/or material flow constraints.
• Partner with Production, Quality, Planning, Supply Chain, and Maintenance to resolve process issues, remove constraints, improve manufacturability, and support production schedules.
• Maintain a strong shop floor presence and actively engage with production teams to understand real operating conditions, validate processes, and ensure documentation reflects how work should be performed.
• Support new business opportunities with time and material estimates for manufacturing process development and/or estimated cost for production units.
• Direct and support the timely resolution of issues and complaints. Provide the problem solving techniques, technical analysis, tolerance studies, and data needed to drive sound decision-making and efficient resolution.
• Works and collaborates with outside suppliers in acquiring information for new development requirements or in working through problems, issues, and/or challenges.
• Performs other duties as assigned.

SKILLS AND QUALIFICATIONS

• Deep technical knowledge of multi-axis CNC machining, programming principles, and mechanical assembly methodologies.
• Proficient creating, reading, and interpreting 3D models and drawings in CAD (i.e. Solidworks) and other design specifications (e.g. heat treat, finishing, coatings, etc.).
• Good understanding of

ASME Y14.5

Geometric Dimensioning & Tolerancing (GD&T) and how it relates to the design, manufacturing, inspection, and assembly processes or procedures.

• Strong working knowledge of medical device regulatory requirements, specifically FDA QMSR and

ISO 13485

standards, preferred.

• Strong experience in problem solving and analysis, such as tolerance stack-ups and stress analysis of loading conditions on a design for assembly or manufacturing processes.
• Able to apply statistical methods to analyze data for problem solving, testing, manufacturing, inspection, and assembly processes.
• Able to gather information and data quickly and efficiently for analysis to provide direction and guidance for good decision making.

EDUCATION AND EXPERIENCE

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related discipline
• 10+ years of experience in manufacturing engineering with a strong emphasis on precision CNC machining and complex assembly processes.
• 5+ years of direct leadership experience managing engineering teams, preferably including machine shop or model shop environments.

LANGUAGE SKILLS

Must possess ability to read, write, speak clearly and succinctly, and comprehend the English language. Ability to read, analyze, and interpret complex documents. Ability to respond effectively to sensitive inquiries or complaints. Ability to prepare presentations and articles using original or innovative techniques or style.

MENTAL, PHYSICAL AND VISUAL DEMANDS

The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 50 pounds. The employee may be required to conduct inspections under magnification. We are an Equal Employment Opportunity ("EEO") Employer. We are an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. The Company makes hiring decisions based solely on qualifications, merit, and business needs at the time

Pay:

$170,000.00 - $190,000.00 per year

Benefits:

401(k) Dental insurance Flexible schedule Health insurance Paid time off Vision insurance Application Question(s): Have you worked in Powered Medical Devices? Do you have Orthopedic powered device experience?

Experience:

CNC:

3 years (Required)

Work Location:

In person