NPI Engineer (Product Development)

Job Purpose

• 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.  

Key Responsibilities

• Materials Science Expertise: Support analysis and interpretation of metallic materials, particularly Titanium alloys, as they transform through the manufacturing process. 

• Manufacturing Process Development: Design and execute experiments that help define manufacturing process windows. 

• Process Qualification: 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. 

• Process Implementation: 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. 

• Process Documentation: Write and maintain detailed work instructions, standard operating procedures (SOPs), and process documentation to ensure repeatable and high-quality production. 

• NPI Process Design: 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. 

• Process Improvement: Identify opportunities for process improvements aimed at scrap reduction and cost savings using root cause analysis, lean tools, and data-driven decision-making. 

Qualifications

• 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 

Preferred Qualifications

• 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 

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 $106,500 to $146,000