Sr. Product Systems Engineer, Med Devices

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

401(k) with company match

Job summary

VulcanForms Inc. is seeking a Senior Product Systems Engineer, Medical Devices to own manufacturing systems from build plate to finished product. You will set process architecture, lead process standardization, and mentor engineers ensuring robust, data-driven operations.

You will collaborate across operations, quality, and digital teams to optimize end-to-end flow, drive Kaizen initiatives, and govern process documentation and ERP standards. This role reports to the Operations Program Manager.

Qualifications

• Bachelor’s degree in Mechanical, Materials, Manufacturing, or Biomedical Engineering; advanced degree a plus.
• 5+ years 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.

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 bottlenecks to attack and ensuring sustained improvement.
• Define standards and templates for methods of manufacture in our ERP system and govern how customer requirements are encoded.
• 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.
• Serve as the escalation point for complex process failures between printing and final delivery and drive corrective action.
• Mentor associate and mid-level product engineers, reviewing their process designs and documentation.

Skills

Process ownership

Regulated manufacturing

Cross-functional leadership

Kaizen methodology

Mentoring engineers

Education

Bachelor’s degree in Mechanical/ Materials/ Manufacturing/ Biomedical Engineering

Advanced degree preferred

Tools

SQL

Power BI

Tableau

MES/ERP data

Job description

VulcanForms Inc. is seeking a Senior Product Systems Engineer, Medical Devices to own manufacturing systems from build plate to finished product. You will set process architecture, lead process standardization, and mentor engineers ensuring robust, data-driven operations.

You will collaborate across operations, quality, and digital teams to optimize end-to-end flow, drive Kaizen initiatives, and govern process documentation and ERP standards. This role reports to the Operations Program Manager.