Job PurposeAs the Director, Product Development Engineering (CNC Machining) at VulcanForms, you will serve as the strategic technical executive responsible for leading, scaling, and unifying our medical device product development engineering organization for precision subtractive manufacturing. In this high-visibility role, you will architect the overarching engineering strategy for multi-axis CNC machining platforms (5-axis milling, Swiss turning, EDM), advanced CAM workflows, fixture design, and post-processing integration specifically tailored for high-consequence medical device applications. Products in this portfolio are manufactured through laser Powder Bed Fusion (LPBF), with CNC machining performed on 3D-printed, near-net-shape substrates to achieve final geometry, tolerances, and surface finish. You will own the phase-gated pathway from medical device design input through process validation and a formal handover to Operations for full-rate serial production-translating customer requirements into scalable engineering frameworks that set industry standards for dimensional accuracy, surface finish, system reliability, and yield across our commercial medical programs. You will manage and grow a multidisciplinary team of senior, principal, and product development engineers while acting as a key technical authority across hardware, software, tooling, quality, and operations. By establishing rigorous engineering governance, driving Design for Manufacturability (DFM) methodologies, building robust inspection strategies, optimizing manufacturing workflows, and expanding customer technical partnerships, you will ensure VulcanForms delivers production-ready, implantable, and surgical-grade components for our most strategic medical device customers.
Key Responsibilities- Executive Engineering Leadership & Strategy: Define and execute the long-term roadmap for medical device product development engineering for subtractive (CNC) manufacturing, from customer design input through production release; establish organizational KPIs, engineering governance, and resource loading models to support rapid company scaling.
- Phase-Gated Development & Transfer to Operations: Govern the end-to-end framework for transitioning complex multi-axis CNC machining processes, fixture architectures, and digital CAM workflows through a phase-gated development process (feasibility, process development, verification and validation via IQ/OQ/PQ, and pilot production) into high-volume serial production; define gate entry/exit criteria and lead a formal handover to Operations covering released process documentation, control plans, trained operators, and demonstrated process capability (Cpk), with defined post-transfer sustaining support.
- Team Building & Talent Development: Build, mentor, and retain a world-class team of product development engineers, CAM programmers, tooling specialists, and technical leads; cultivate a culture of technical excellence, accountability, and continuous improvement.
- Strategic Customer & Executive Engagement: Serve as the primary technical authority for tier-one medical device OEM customers, executive leadership, and strategic partners; lead high-stakes technical reviews, program launches, and co-development initiatives.
- Top-Down DFM & Cross-Functional Governance: Institutionalize advanced Design for Manufacturability and Inspectability (DFM/DFI) methodologies, applied early in the medical device design cycle and tailored to precision CNC machining (milling, turning, grinding, EDM) and ensure seamless cross-functional integration with upstream processes (e.g., LPBF blank feeds) and downstream operations (heat treatment, passivation, surface finishing, and automated CMM inspection).
- Manufacturing Workflow Optimization & Yield: Optimize end-to-end manufacturing workflows (cycle time, setup reduction, toolpath and fixture strategy, work-cell flow, and in-process automation) using lean and value stream mapping; drive organization-wide corrective and preventive action (CAPA) frameworks for complex machining defects, tool wear anomalies, and geometric stack-up issues, leveraging advanced data analytics, statistical process control (SPC), and iterative testing to maximize yield.
- Inspection Methods, Quality & Compliance: Define risk-based inspection strategies across CMM, optical/vision metrology, surface roughness measurement, in-process probing, and CT scanning; lead test method validation (TMV) and measurement system analysis (gauge R&R); establish and govern standardized operating procedures (SOPs), tooling/fixturing baselines, First Article Inspection (FAI) protocols, and engineering change management processes compliant with ISO 13485 and FDA QMSR (21 CFR 820) requirements.
Qualifications- 10+ years of progressive engineering and technical leadership experience in advanced subtractive manufacturing, with a proven track record of building and managing high-performing engineering teams in multi-axis CNC machining (5-axis milling, Swiss turning, EDM) for implantable and surgical medical device product development.
- Bachelor's degree in Mechanical, Manufacturing, Aerospace, or Systems Engineering; Master's degree is preferred.
- Demonstrated executive presence with a track record of driving cross-functional alignment across R&D, Operations, Quality, and Commercial teams while serving as a trusted technical partner to C-suite leadership and external customers.
- Deep mastery of precision subtractive manufacturing fundamentals, including advanced multi-axis CNC machining, fixture design, tool path optimization, metallurgy, complex GD&T (ASME Y14.5), inspection methods (CMM, optical/vision metrology, surface profilometry, in-process probing, and CT), measurement system analysis (gauge R&R), and statistical process control (SPC).
- Proven experience leading phase-gated medical device product development, through design transfer, process validation (IQ/OQ/PQ), and formal handover to Operations for full-rate serial production, under ISO 13485 and 21 CFR 820.
- Strong expertise in manufacturing workflow optimization (lean, value stream mapping, cycle-time and setup reduction) and integrated manufacturing workflows, including hybrid manufacturing (additive-to-subtractive workflows), passivation, electropolishing, cleanroom packaging, and non-destructive testing (NDT).
- Practical, hands-on manufacturing skills, including medical device cleaning and cleaning validation, cleanroom packaging and sterile barrier systems, and QC inspection (receiving, in-process, and final inspection using CMM, optical comparators, and manual gauging), with the ability to work directly on the shop floor alongside technicians and operators.
Preferred Qualifications- Prior experience building or scaling product development or application engineering departments within high-growth medical device or advanced manufacturing technology companies.
- Experience processing 3D-printed metal substrates (e.g., LPBF parts), including datum establishment on as-built geometry, support removal, stock allowance management, and machining of near-net-shape features.
- Experience with enterprise-level CAD/CAM software, machining simulation tools, and digital manufacturing suites (e.g., Siemens NX CAM, Mastercam, Esprit, Vericut).
- Hands-on familiarity with medical-grade materials (Titanium Ti-6Al-4V ELI, CoCr, Stainless Steel 316L/17-4PH, PEEK) and associated cutting tool physics/coolant delivery methodologies.
- Certified Quality Engineer (CQE) or Six Sigma Black Belt credentials.
VulcanForms offers a competitive salary and equity package. Actual compensation is based on factors such as the candidate's skills, qualifications, and experience. In addition, VulcanForms provides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with company match.
The annual base salary range for this position is $176,000 to $242,000
