
Senior Product Systems Engineer
Required skills
- manufacturing systems
- process architecture
- advanced manufacturing
- automation
- lean manufacturing
- ERP system
- process validation
- IQ/OQ/PQ
- metal manufacturing
- additive manufacturing
Nice to have
- associate product engineer
- mid-level product engineer
- process dashboards
- value stream
Role summary
VulcanForms is seeking a Senior Product Systems Engineer for their Medical Devices division. This role involves owning the manufacturing systems from production to finished product, setting process architecture using advanced manufacturing, automation, and lean methods. Responsibilities include designing system flows, data infrastructure, leading improvement events, managing process documentation, building dashboards, and mentoring junior engineers. The ideal candidate has a Bachelor's degree in a relevant engineering field, 5+ years of manufacturing/process engineering experience (3+ in regulated medical devices), and knowledge of FDA regulations, metal manufacturing processes, and MES/ERP data reporting.
Job Purpose
As 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 Details
Location: 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.
Similar roles
Staff Project Manager – Digital Manufacturing, Consumer TechnologyVulcanForms Inc. · Devens, MA · Onsite
Staff Product Development Engineer, IndustrialsVulcanForms Inc. · Newburyport, MA · Onsite
Staff Product Systems Engineer - EV Charging/V2XGeneral Motors · Warren, MI · Hybrid- Product Systems Engineer - Unmanned Aircraft SystemsTrellisWare Technologies · San Diego, CA · Onsite
Systems EngineerMind Robotics · Palo Alto, CA · Onsite- Systems Engineer IIILVT · American Fork, UT · Onsite
