VulcanForms
Senior Product Systems Engineer
$100K–$137K
Devens, MA · On-site · Senior · Full-time · Posted Sep 16, 2026
- Experience
- 5+ years of manufacturing or process engineering experience; at least 3 years in a regulated medical device environment preferred.
- Education
- Bachelor's degree in Mechanical, Materials, Manufacturing, or Biomedical Engineering, or a related discipline; advanced degree a plus.
About the job
Own and improve end-to-end manufacturing systems that move medical-device parts from additive builds through inspection and final delivery.
What you'll do
- Design factory-wide product flow, process architecture, standards, and ERP methods of manufacture.
- Lead continuous improvement, build process dashboards, and resolve complex manufacturing failures through root cause analysis and corrective action.
- Govern process and quality documentation, and mentor product engineers on process design and documentation.
What they ask for
- Bachelor's degree in Mechanical, Materials, Manufacturing, or Biomedical Engineering, or a related discipline.
- Demonstrated system-level ownership of a manufacturing process or value stream.
- Working knowledge of FDA 21 CFR Part 820, including design controls and IQ/OQ/PQ process validation.
- Deep working knowledge of additive and subtractive metal manufacturing; experience with MES/ERP reporting or dashboards and cross-functional improvement work.
Nice to have
- Advanced degree.
- At least 3 years in a regulated medical device environment.
Pay
$100,000 to $137,000 (annual base salary)
Tools
ERP, MES, SQL, Power BI, Tableau, FDA 21 CFR Part 820, IQ/OQ/PQ
Model-written summary · the original posting is authoritative