Job PurposeAs a Senior Product Systems Engineer, Medical Devices at VulcanForms, you will own the manufacturing systems that carry our printed parts from the build plate to a finished, inspected product. You will set the process architecture across product families - advanced manufacturing techniques, automation, and lean manufacturing methods - and define the standard that individual part processes are built against.
You will design the systems, procedures, and data infrastructure that let product move seamlessly through the plant, and you will mentor the product engineers who build and maintain the part-level processes within them.
Key Responsibilities- Partner with operations, quality, the digital team, and the enterprise teams to design how product flows through the factory end to end.
- Lead Kaizen events, selecting which bottlenecks to attack and holding teams accountable for sustained improvement.
- Define the standards and templates for methods of manufacture in our ERP system, and govern how part-specific customer requirements are encoded against them.
- Own the process and quality documentation system - structure, configuration control, and revision governance.
- Build bespoke process dashboards that give execution teams visibility across the value stream, partnering with the digital team on data sources and models.
- Serve as the escalation point for complex process failures between printing and final delivery, driving root cause analysis and corrective action.
- Mentor associate and mid-level product engineers, reviewing their process designs, methods of manufacture, and documentation.
Qualifications- Bachelor's degree in Mechanical, Materials, Manufacturing, or Biomedical Engineering, or a related discipline; advanced degree a plus.
- 5+ years of manufacturing or process engineering experience, preferred at least 3 years in a regulated medical device environment.
- Demonstrated ownership of a manufacturing process or value stream at the system level, not solely at the individual 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 both additive and subtractive methods.
- Experience building reporting or dashboards from MES/ERP data (e.g., SQL, Power BI, Tableau).
- Experience leading cross-functional improvement work without direct reporting authority.
Additional DetailsLocation: Onsite at [Devens, MA]
Reports to: Operations Program Manager
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 $100,000 to $137,000.
