Senior Product Systems Engineer

RiseMe; Harvard (MA); On-site; USD 100,000 - 137,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

Life Insurance

401(k) with company match

Generous PTO

Job summary

VulcanForms in Devens, MA seeks a Senior Product Systems Engineer, Medical Devices to own the manufacturing systems that move printed parts from the build plate to finished, inspected products. You will set the process architecture across families and define the standard that part processes are built against.

You will mentor engineers, design systems and data infrastructure, and partner across operations to drive end-to-end flow and quality improvements in a regulated environment.

Qualifications

• Bachelor's degree in Mechanical, Materials, Manufacturing, or Biomedical Engineering; advanced degree a plus.
• 5+ years of manufacturing or process engineering experience; medical device regulatory experience preferred.
• Experience with FDA 21 CFR Part 820, design controls and IQ/OQ/PQ.

Responsibilities

• Partner with operations, quality, the digital team, and 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 with the digital team to provide visibility across the value stream.
• Serve as 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 process designs and documentation.

Skills

Manufacturing Engineering

Process Ownership

Regulated Medical Devices

Design Controls

Data Dashboards

Cross-functional Leadership

Education

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

Advanced degree preferred

Tools

SQL

Power BI

Tableau

Job description

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

VulcanFormsoffers a competitive salary and equitypackage.Actual compensation is based on factors such as the candidate's skills, qualifications, and experience.In addition,VulcanFormsprovides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with companymatch.

The annual base salary range for this position is $100,000 to $137,000.