Senior NPD Manufacturing Engineer, Medical Devices

Instylla, Inc.; Burlington (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Instylla, Inc. in Bedford, MA, seeks a Senior Advanced Manufacturing Engineer to drive NPD manufacturing development for embolic product lines.

You will own the Master Validation Plan (MVP), equipment qualification, and process validation, partnering with R&D, Production, Quality, Regulatory, and Supply Chain to deliver robust, scalable processes ready for transfer to Operations. You will design for manufacturability, engage external suppliers, and drive cost, cycle time, and quality

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field.
• 7+ years in manufacturing engineering for medical devices or regulated industry.
• Experience taking new products from development through design transfer to manufacturing.
• Strong knowledge of DFM/DFM input and collaboration with R&D teams.

Responsibilities

• Lead NPD manufacturing engineering on core teams from concept through design transfer.
• Provide DFM/DFA input during design development and reviews to ensure manufacturability and cost-effectiveness.
• Translate design inputs into process requirements, CTQ characteristics, and process specs.
• Lead pFMEA and contribute to risk management files.
• Partner with external suppliers and internal teams to qualify processes and implement MVP.

Skills

DFM input

DFM/DFA

Process development

Statistical methods

Gage R&R

DOE

Minitab

Project management

Quality systems

Education

Bachelor's degree in Biomedical Engineering or related

Master's degree (preferred)

Tools

SolidWorks

GD&T

ERP systems (QAD/Oracle/SAP)

Job description

Instylla, Inc. in Bedford, MA, seeks a Senior Advanced Manufacturing Engineer to drive NPD manufacturing development for embolic product lines.

You will own the Master Validation Plan (MVP), equipment qualification, and process validation, partnering with R&D, Production, Quality, Regulatory, and Supply Chain to deliver robust, scalable processes ready for transfer to Operations. You will design for manufacturability, engage external suppliers, and drive cost, cycle time, and quality