Manufacturing Engineer

Midwest Interventional Systems Inc; Maple Grove (MN); Sur place; USD 80 000 - 105 000; Plein temps

Avantages offerts par ce poste

Flexible PTO

9 paid holidays

Health, Dental, Vision coverage

HSA & employer contribution

401(k) & employer contribution

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Lean Six Sigma

Project coordination

Regulatory compliance

Formation

Bachelor's degree in Mechanical or Biomedical Engineering

Outils

SolidWorks 3D CAD

Description du poste

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

About the Organization We are a dedicated and multidisciplinary group of problem solvers with decades of engineering expertise. As a leader in complex catheter development we have assembled a team of world class engineers that don't shy away from challenges.

Position Process Development Engineer

Description

The Process Development Engineer will lead the design, development, and optimization of manufacturing processes for medical devices in compliance with regulatory standards (ISO 13485, FDA 21 CFR Part 11). This role involves collaborating with cross-functional teams to ensure robust, scalable, and cost-effective processes that meet customer requirements and quality standards.

Duties and Responsibilities

• Develop and validate new manufacturing processes for medical devices, ensuring compliance with regulatory and quality requirements.
• Draft and/or contribute to essential documents (i.e. MPI’s, Inspection Plans, LHR’s, DMR’s, IQ/OQ/PQ Protocols, Process Flow Diagrams, PFMEAs, Control Plans, and Calibration /PM Requirements).
• Initiate process innovation, process development and improvement in terms of cost reduction, yield improvement, and increased efficiencies on catheter product lines.
• Implement Lean and Six Sigma methodologies to reduce variability and improve throughput.
• Coordinate production operations with the requirements for finished products and the need for materials and labor.
• Performs, demonstrates, and trains new employees on all pertinent manufacturing processes and quality requirements.
• Provide technical leadership in the areas assigned and provide “Design for Manufacturing” input to Design Services and customers.
• Design and implement new tooling, fixturing, and capital equipment.
• Work closely with the engineering group to assist and coordinate project transfers from development to production.
• Establish product requirements, prototypes, design and development (including verification and validation), risk assessment, performance and safety testing for new products.
• Maintains detailed documentation throughout all phases of manufacturing development and transfer phases.
• Reviews or coordinates outside vendor activities to support development.
• Interface with customers and internal departments articulating team activities and progress.
• Other duties as assigned.

Position Requirements

Education, Experience, Skills

• Bachelor's degree in Mechanical or Biomedical Engineering is desired. In lieu of a degree, previous experience in a similar or exact role will be considered.
• 3-5 years of medical device design and development experience is required
• Familiarity with FDA QSR and ISO 13485 medical device regulations.
• SolidWorks 3D CAD proficiency is required.
• Familiarity with design for catheters and extrusions is required.
• Familiarity with reinforced shaft, delivery systems, and steerable catheters is required.

Compensation & Benefits

Salary range: $80,000 - $105,000

The following benefits are available to full-time employees:

• Flexible PTO & sick time
• 9 paid company holidays
• Health, Dental, & Vision coverage
• Short- & Long-Term Disability opt-in
• Health Savings Account (HSA) & employer contribution
• 401(k) & employer contribution

Exempt/Non-Exempt Non-Exempt

Full-Time/Part-Time Full-Time

Open Date 8/19/2026

This position is currently accepting applications.