Senior Product Systems Engineer - Med Devices, Process Lead

Socket.dev; 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

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.