Senior Product Systems Engineer

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

Founded in 2015 to develop the world’s first industrially scalable laser metal additive manufacturing solution, VulcanForms is reshaping how the world manufactures critical products. We build and operate advanced digital infrastructure that enables innovation, accelerates growth, and supports sustainability across aerospace, defense, medical, and other essential industries. Through our vertically integrated capabilities, including scalable additive manufacturing and precision machining, we deliver true end-to-end production at scale by combining cutting-edge technology with a foundation of proven industrial craftsmanship. Our team brings deep expertise in manufacturing, materials science, software, automation, and operations, united by a shared commitment to quality, curiosity, and accountability. We foster an inclusive culture where people take ownership, solve meaningful problems, and continuously learn, because we believe diverse perspectives lead to better outcomes.

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.

Reports to: Operations Program Manager

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.