Director, Product Development Engineering (CNC Machining)

VulcanForms Inc.•Devens, MA

1d•$176,000 - $242,000

About The Position

The Director, Product Development Engineering (CNC Machining) at VulcanForms is the strategic technical executive responsible for leading, scaling, and unifying the medical device product development engineering organization for precision subtractive manufacturing. The role sets engineering strategy for multi-axis CNC machining platforms—including 5-axis milling, Swiss turning, and EDM—along with advanced CAM workflows, fixture design, and post-processing integration for high-consequence medical device applications. The products are manufactured through laser Powder Bed Fusion (LPBF), with CNC machining used on 3D-printed, near-net-shape substrates to achieve final geometry, tolerances, and surface finish. The director owns the phase-gated pathway from medical device design input through process validation and formal handover to Operations for full-rate serial production. The role translates customer requirements into scalable engineering frameworks and standards for dimensional accuracy, surface finish, system reliability, and yield across commercial medical programs. It manages and grows a multidisciplinary team of senior, principal, and product development engineers, and serves as a technical authority across hardware, software, tooling, quality, and operations. The director establishes engineering governance, advances Design for Manufacturability (DFM), develops inspection strategies, optimizes manufacturing workflows, and expands customer technical partnerships to deliver production-ready, implantable, and surgical-grade components. VulcanForms offers a competitive salary and equity package. The annual base salary range is $176,000 to $242,000. Compensation depends on factors such as the candidate’s skills, qualifications, and experience. Benefits include medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with company match.

Requirements

10+ years of progressive engineering and technical leadership experience in advanced subtractive manufacturing, including building and managing engineering teams in multi-axis CNC machining for implantable and surgical medical device product development.
Bachelor’s degree in Mechanical, Manufacturing, Aerospace, or Systems Engineering.
Demonstrated executive presence and experience driving cross-functional alignment across R&D, Operations, Quality, and Commercial teams, and serving as a trusted technical partner to C-suite leadership and external customers.
Deep knowledge of precision subtractive manufacturing, including multi-axis CNC machining, fixture design, toolpath optimization, metallurgy, complex GD&T (ASME Y14.5), inspection methods, measurement system analysis (gauge R&R), and SPC.
Experience leading phase-gated medical device product development through design transfer, process validation (IQ/OQ/PQ), and formal handover to Operations for serial production under ISO 13485 and 21 CFR 820.
Expertise in manufacturing workflow optimization, including lean methods, value stream mapping, cycle-time and setup reduction, and integrated workflows involving additive-to-subtractive manufacturing, passivation, electropolishing, cleanroom packaging, and non-destructive testing.
Hands-on manufacturing skills, including medical device cleaning and cleaning validation, cleanroom packaging and sterile barrier systems, and receiving, in-process, and final QC inspection using CMM, optical comparators, and manual gauging.
Ability to work directly on the shop floor alongside technicians and operators.

Nice To Haves

Master’s degree.
Experience building or scaling product development or application engineering departments at high-growth medical device or advanced manufacturing technology companies.
Experience processing 3D-printed metal substrates such as LPBF parts, including datum establishment on as-built geometry, support removal, stock allowance management, and machining near-net-shape features.
Experience with enterprise CAD/CAM software, machining simulation tools, and digital manufacturing suites such as Siemens NX CAM, Mastercam, Esprit, or Vericut.
Hands-on familiarity with medical-grade materials including Titanium Ti-6Al-4V ELI, CoCr, Stainless Steel 316L/17-4PH, and PEEK, and with associated cutting-tool physics and coolant delivery methods.
Certified Quality Engineer (CQE) or Six Sigma Black Belt credentials.

Responsibilities

Define and execute the long-term roadmap for medical device product development engineering for CNC subtractive manufacturing, from customer design input through production release; establish organizational KPIs, engineering governance, and resource-loading models.
Govern phase-gated development and transfer of CNC machining processes, fixture architectures, and digital CAM workflows through feasibility, process development, verification and validation (IQ/OQ/PQ), and pilot production into serial production.
Define gate entry and exit criteria and lead formal handover to Operations, including released process documentation, control plans, trained operators, demonstrated process capability (Cpk), and post-transfer sustaining support.
Build, mentor, and retain product development engineers, CAM programmers, tooling specialists, and technical leads; foster technical excellence, accountability, and continuous improvement.
Serve as the primary technical authority for tier-one medical device OEM customers, executive leadership, and strategic partners; lead technical reviews, program launches, and co-development initiatives.
Institutionalize DFM and Design for Inspectability (DFI) methodologies early in medical device design and ensure integration with upstream LPBF blank feeds and downstream heat treatment, passivation, surface finishing, and automated CMM inspection.
Optimize manufacturing workflows, including cycle time, setup reduction, toolpath and fixture strategy, work-cell flow, and in-process automation, using lean methods and value stream mapping.
Lead corrective and preventive action (CAPA) frameworks for machining defects, tool wear anomalies, and geometric stack-up issues, using data analytics, statistical process control (SPC), and iterative testing to improve yield.
Define risk-based inspection strategies using CMM, optical/vision metrology, surface roughness measurement, in-process probing, and CT scanning; lead test method validation and measurement system analysis (gauge R&R).
Establish and govern SOPs, tooling and fixturing baselines, First Article Inspection protocols, and engineering change management compliant with ISO 13485 and FDA QMSR (21 CFR 820).