Process Development Engineer - Medical Devices | Flex PTO

Midwest Interventional Systems Inc; Maple Grove (MN); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Flexible PTO

9 paid holidays

Health, Dental, Vision coverage

HSA & employer contribution

401(k) & employer contribution

Job summary

Midwest Interventional Systems Inc is seeking a Process Development Engineer to lead the design, development, and optimization of manufacturing processes for medical devices. The role ensures regulatory and quality compliance, collaboration with cross-functional teams, and scalable processes that meet customer requirements.

Experience with Lean/Six Sigma, catheters, and extrusion processes is essential. Bachelor’s degree in Mechanical or Biomedical Engineering and 3–5 years in medical device

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering or equivalent experience.
• 3-5 years of medical device design and development experience.
• Familiarity with FDA QSR and ISO 13485 medical device regulations.
• SolidWorks CAD proficiency.
• Familiarity with catheter design and extrusions.

Responsibilities

• Develop and validate manufacturing processes for medical devices in compliance with regulatory and quality requirements.
• Draft and/or contribute to essential documents (e.g., MPI’s, Inspection Plans, LHR’s, DMR’s, IQ/OQ/PQ Protocols, PFMEAs, Control Plans, Calibration/PM requirements).
• Lead process innovation to improve cost, yield, and throughput on catheter product lines.
• Apply Lean and Six Sigma methodologies to reduce variability and improve production efficiency.
• Coordinate production operations with finished goods, materials, and labor requirements.
• Train new employees on manufacturing processes and quality requirements.

Skills

Lean Six Sigma

Project coordination

Regulatory compliance

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks 3D CAD

Job description

Midwest Interventional Systems Inc is seeking a Process Development Engineer to lead the design, development, and optimization of manufacturing processes for medical devices. The role ensures regulatory and quality compliance, collaboration with cross-functional teams, and scalable processes that meet customer requirements.

Experience with Lean/Six Sigma, catheters, and extrusion processes is essential. Bachelor’s degree in Mechanical or Biomedical Engineering and 3–5 years in medical device