NPI Engineer (Product Development)

VulcanForms Inc.•Devens, MA

20d•$106,500 - $146,000

About The Position

The Senior Development Engineer will design and validate manufacturing processes that deliver safe, efficient processes that meet quality, cost, capacity, and customer requirements. This role is within the Medical Device Business Unit and will support the NPI teams in developing manufacturing processes for new metallic implantable products. This role combines materials science, manufacturing process design, and quality-first process validations to deliver robust manufacturing processes for medical devices.

Requirements

Bachelor’s degree in Mechanical, Manufacturing, or Materials Science (or related field)
Demonstrated expertise in materials science of metals, particularly titanium alloys.
5+ years of experience in process design and qualification, with a particular focus on 3D printing technologies such as laser metal powder bed fusion.
Hands-on experience developing and scaling production processes
Proficiency in process qualification tools and methods (e.g., PFMEA, DOE, IQ/OQ/PQ)
Strong cross-functional collaboration skills, including working with suppliers, technicians, and internal engineering, quality, and production teams
Experience creating and maintaining process documentation (e.g., SOPs, work instructions, validation plans)
Knowledge of Lean Manufacturing, root cause analysis, and continuous improvement methods

Nice To Haves

Familiarity with post-processing techniques, GD&T, and tooling design (hands-on or oversight)
Background in regulated or quality-controlled environments (e.g., medical device, aerospace) and experience qualifying equipment or automated processes
Exposure to ERP/MES systems, manufacturing data tools, and safety or ergonomic assessments

Responsibilities

Support analysis and interpretation of metallic materials, particularly Titanium alloys, as they transform through the manufacturing process.
Design and execute experiments that help define manufacturing process windows.
Author protocols and reports that support process validations such as Operational and Performance Qualifications (OQ/PQ), which will include understanding process control logic, materials test methods, and statistical sample sizes.
Oversee the implementation of manufacturing processes by collaborating with in-house technicians and external suppliers. Coordinate machine setup and process validation while maintaining technical ownership.
Write and maintain detailed work instructions, standard operating procedures (SOPs), and process documentation to ensure repeatable and high-quality production.
Engage in the NPI process as required to understand part requirements and contribute to design-for-manufacturability (DFM) decisions. Work closely with design, quality, and production teams to align on cost, capability, and scalability.
Identify opportunities for process improvements aimed at scrap reduction and cost savings using root cause analysis, lean tools, and data-driven decision-making.