Director, Product Development Engineering (Laser Powder Bed Fusion)

VulcanForms Inc.; Ayer (MA); On-site; USD 176,000 - 242,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Generous paid time off

401(k) plan with company match

Job summary

VulcanForms Inc. seeks a Director of Product Development Engineering (Laser Powder Bed Fusion) to lead the creation of next‑gen medical devices on LPBF platforms, guiding programs from concept through validation and production transfer.

You will mentor a multidisciplinary team, partner with Quality, Regulatory, Operations, and Commercial teams, and ensure DfAM, process development, and design controls meet ISO 13485 and ISO 14971 requirements while delivering reliable, scalable solutions.

Qualifications

• 10+ years of progressive engineering and technical leadership experience in medical device product development or advanced manufacturing.
• Bachelor's degree in Mechanical, Biomedical, Materials, or Systems Engineering; Master's degree or Ph.D. is highly preferred.
• Demonstrated success managing customer relationships as a trusted technical partner to OEM engineering and quality teams.
• Deep mastery of additive manufacturing fundamentals, including process optimization, metallurgy, and design for AM.
• Proven experience taking new medical device products from concept through design verification, process validation, and production launch under ISO 13485 design controls.
• Strong expertise in integrated manufacturing workflows, including subtractive machining and post-processing metallurgy.

Responsibilities

• Lead development of medical device products on LPBF platforms from customer concept through transfer to production.
• Own parameter development, build preparation, and process validation (IQ/OQ/PQ) for new products.
• Lead, mentor, and develop a team of product development engineers and technical leads.
• Serve as the primary technical contact for medical device customers and lead design reviews and program updates.
• Act as technical authority on DfAM for medical applications and ensure integration with downstream operations.
• Lead root cause investigations and yield improvement using data analytics and SPC.
• Ensure design controls and risk management practices compliant with ISO 13485 and ISO 14971.

Skills

Engineering leadership

Medical device product development

Cross-functional collaboration

Project management

Education

Bachelor's degree in Mechanical, Biomedical, Materials, or Systems Engineering

Master's degree or Ph.D. preferred

Tools

Siemens NX

nTopology

Magics

Ansys Additive

Job description

About Us

Founded in 2015 to develop the world's first industrially scalable laser metal additive manufacturing solution, VulcanForms is reshaping how the world manufactures critical products. We build and operate advanced digital infrastructure that enables innovation, accelerates growth, and supports sustainability across aerospace, defense, medical, and other essential industries. Through our vertically integrated capabilities, including scalable additive manufacturing and precision machining, we deliver true end-to-end production at scale by combining cutting-edge technology with a foundation of proven industrial craftsmanship. Our team brings deep expertise in manufacturing, materials science, software, automation, and operations, united by a shared commitment to quality, curiosity, and accountability. We foster an inclusive culture where people take ownership, solve meaningful problems, and continuously learn, because we believe diverse perspectives lead to better outcomes.

About Us

Founded in 2015 to develop the world's first industrially scalable laser metal additive manufacturing solution, VulcanForms is reshaping how the world manufactures critical products. We build and operate advanced digital infrastructure that enables innovation, accelerates growth, and supports sustainability across aerospace, defense, medical, and other essential industries. Through our vertically integrated capabilities, including scalable additive manufacturing and precision machining, we deliver true end-to-end production at scale by combining cutting-edge technology with a foundation of proven industrial craftsmanship. Our team brings deep expertise in manufacturing, materials science, software, automation, and operations, united by a shared commitment to quality, curiosity, and accountability. We foster an inclusive culture where people take ownership, solve meaningful problems, and continuously learn, because we believe diverse perspectives lead to better outcomes.

Job Purpose

As the Director, Product Development Engineering (Laser Powder Bed Fusion) at VulcanForms, you will lead the development of new medical device products on our high-speed laser powder bed fusion (LPBF) platforms, taking customer programs from concept and design through process development, validation, and production launch. In this hands-on, customer-facing role, you will serve as the trusted technical partner to our medical device customers, building long-term relationships with their engineering, quality, and supply chain teams and translating their clinical and design requirements into manufacturable LPBF products. You will provide technical leadership on implants, surgical instruments, and other critical medical components—guiding DfAM, build preparation, post-processing, and verification activities so that new products launch with the print quality, reliability, and yield that regulated medical applications demand. You will lead, mentor, and grow a multidisciplinary team of product development engineers, and partner closely with Quality, Regulatory, Operations, and Commercial teams to deliver each program on time. By combining deep LPBF expertise, disciplined design controls, and strong customer relationships, you will make VulcanForms the development and manufacturing partner of choice for leading medical device companies.

Key Responsibilities

• Medical Device Product Development: Lead the development of new medical device products on VulcanForms' LPBF platforms, from customer concept and design inputs through DfAM, process development, design verification, and transfer to production.
• LPBF Process Development & Validation: Own parameter development, build preparation, and process validation (IQ/OQ/PQ) for new products, delivering robust, repeatable LPBF processes that meet medical device material, dimensional, and cleanliness requirements.
• Engineering Team Leadership: Lead, mentor, and develop a team of product development engineers, application specialists, and technical leads; set clear priorities across concurrent customer programs, coach engineers on technical and customer-facing skills, and foster a culture of technical excellence, accountability, and continuous improvement.
• Customer Relationship Management: Serve as the primary technical point of contact for medical device customers, building trusted, long-term relationships with their engineering, quality, and supply chain teams; lead design reviews, program updates, and co-development initiatives, and partner with Commercial to identify and grow new product opportunities.
• Technical Leadership in DfAM & DFM: Act as the technical authority on Design for Additive Manufacturing (DfAM) for medical applications, guiding customers and internal teams on lattice and porous structures, part orientation, and supports, and ensuring integration with downstream operations, including 5-axis machining, heat treatment, surface finishing, and automated inspection.
• Root Cause & Yield Improvement: Lead technical investigations of print defects and nonconformances on new products, applying data analytics, statistical process control, and iterative testing to drive corrective actions and improve yield before and after launch.
• Standards, Quality & Compliance: Ensure new product development follows design control and risk management practices compliant with ISO 13485 and ISO 14971 and supports customers' regulatory submissions; maintain First Article Inspection (FAI), engineering change, and documentation practices for medical programs.

Qualifications

• 10+ years of progressive engineering and technical leadership experience in medical device product development or advanced manufacturing, with a proven track record of leading high-performing engineering teams in metal additive manufacturing (LPBF strongly preferred).
• Bachelor's degree in Mechanical, Biomedical, Materials, or Systems Engineering; Master's degree or Ph.D. is highly preferred.
• Demonstrated success managing customer relationships as a trusted technical partner to OEM engineering and quality teams, with the ability to drive cross-functional alignment across R&D, Operations, Quality, Regulatory, and Commercial teams.
• Deep mastery of additive manufacturing fundamentals, including process optimization, metallurgy, complex build preparation, GD&T, and statistical process control (SPC).
• Proven experience taking new medical device products from concept through design verification, process validation, and production launch under ISO 13485 design controls.
• Strong expertise in integrated manufacturing workflows, including subtractive machining (5-axis milling, turning, EDM), post-processing metallurgy, and non-destructive testing (NDT).

Preferred Qualifications

• Experience developing additively manufactured orthopedic, spinal, or surgical instrument products, including porous and lattice structures for implants.
• Experience with enterprise-level build preparation and simulation tools (e.g., Siemens NX, nTopology, Magics, Ansys Additive).
• Familiarity with FDA 510(k) submissions, biocompatibility (ISO 10993), and cleaning and sterilization validation for metal implants.

VulcanForms offers a competitive salary and equity package. Actual compensation is based on factors such as the candidate's skills, qualifications, and experience.

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Generous paid time off
• 401(k) plan with company match

The annual base salary range for this position is $176,000 to $242,000.