Senior Product Systems Engineer – Medical Devices (Equity)

VulcanForms Inc.; Ayer (MA); On-site; USD 100,000 - 137,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life insurance

401(k) with company match

Paid time off

Job summary

VulcanForms Inc. in Devens, MA, seeks a Senior Product Systems Engineer, Medical Devices to own the manufacturing systems that move printed parts from the build plate to finished products.

You will define architecture across product families, implementing lean manufacturing methods and mentoring engineers who maintain part-level processes. You will collaborate with operations, quality, and the digital team to improve end-to-end flow and ensure compliance with FDA design controls, process

Qualifications

• Bachelor's degree in Mechanical, Materials, Manufacturing, Biomedical Engineering, or a related discipline; advanced degree a plus.
• 5+ years of manufacturing or process engineering experience, preferred in a regulated medical device environment.
• Experience owning a manufacturing process or value stream at the system level, not just at the part level.
• Working knowledge of FDA 21 CFR Part 820, including design controls and process validation (IQ/OQ/PQ).
• Deep working knowledge of metal manufacturing processes across additive and subtractive methods.
• Experience building reporting or dashboards from MES/ERP data (SQL, Power BI, Tableau).
• Experience leading cross-functional improvement work without direct reporting authority.

Responsibilities

• Partner with operations, quality, the digital team, and enterprise teams to design end-to-end product flows in the factory.
• Lead Kaizen events to attack bottlenecks and drive sustained improvements.
• Define standards and templates for methods of manufacture in the ERP system and encode customer requirements.
• Own the process and quality documentation system with structure, configuration control, and revision governance.
• Build bespoke process dashboards showing value-stream visibility and data sources/models.
• Serve as the escalation point for complex process failures between printing and final delivery, driving RCA and corrective action.
• Mentor associate and mid-level engineers on process designs and documentation.

Skills

Manufacturing process ownership

SQL

Power BI

Tableau

Cross-functional leadership

Education

Bachelor's degree in Mechanical, Materials, Manufacturing, Biomedical Engineering or related

Advanced degree preferred

Tools

MES/ERP data dashboards

Job description

VulcanForms Inc. in Devens, MA, seeks a Senior Product Systems Engineer, Medical Devices to own the manufacturing systems that move printed parts from the build plate to finished products.

You will define architecture across product families, implementing lean manufacturing methods and mentoring engineers who maintain part-level processes. You will collaborate with operations, quality, and the digital team to improve end-to-end flow and ensure compliance with FDA design controls, process