Process Development Technician

Midwest Interventional Systems Inc; Maple Grove (MN); On-site; USD 32,000 - 39,000; Full time

Benefits offered by this job

Paid time off

Company holidays

Health, Dental, Vision coverage

Disability insurance

HSA with employer contribution

401(k) with employer contribution

Job summary

Midwest Interventional Systems Inc in Maple Grove, MN is seeking a Process Development Technician to join our multidisciplinary engineering team. You will build and test catheters, contribute to R&D projects, and help drive the development of new therapies in a cleanroom environment.

The role requires 1+ year in the medical device field, ISO 13485 and FDA Part 820 knowledge, and strong MS Office/Excel skills.

Qualifications

• 1+ years of work experience in the medical device industry.
• Experience with ISO 13485 and FDA 21 CFR Part 820.
• Proficient in MS Office and Excel; strong communication skills.
• Ability to document processes and follow procedures.

Responsibilities

• Build and test catheters and sub-assemblies.
• Support R&D and commercial manufacturing lines.
• Assist with designing new catheters.
• Execute process development activities in a cleanroom environment.
• Document process settings in batch records and notebooks.
• Cross-train team members across value streams.
• Perform in-process and final inspections for quality.
• Follow cleanroom protocols and maintain tidiness.
• Collaborate with internal teams to troubleshoot and improve processes.
• Perform weekly Product Processing Area cleaning.

Skills

Medical device industry experience

Verbal and written communication

Detail oriented

Independent worker

Tools

MS Office

Excel

Job description

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 Technician

Description

The Process Development Technician role is an integral part of the design and development process and works collaboratively with diverse project teams to deliver excellent products and documentation.

Duties & Responsibilities

• Build and test catheters and sub-assemblies to meet the needs of patients and customers.
• Contribute to research and development projects and commercial manufacturing lines.
• Help drive the development of exciting new therapies by assisting with the design of new catheters.
• Execute process development activities on catheter assemblies in a cleanroom environment.
• Utilize common equipment in catheter manufacturing such as braiders, coilers, reflow ovens, tipping equipment, hot jaw bonding, laser bonding, adhesive bonding, etc.
• Document process settings and techniques in a cleanroom notebook for review by R&D engineers.
• Crosstrain other team members, shift to various value streams to undergo cross training.
• Perform in-process and final inspections using visual and mechanical methods to ensure product quality.
• Document production activities accurately in batch records and electronic systems.
• Perform duties in accordance with established procedures, including good documentation practices.
• Follow cleanroom protocols including gowning, material handling, and contamination control.
• Interact with internal teams to explore, troubleshoot and improve designs, fabrication processes and procedures.
• Perform weekly Product Processing Area cleaning as well as keeping daily lab tidiness and cleanliness.
• Perform other duties as needed.

Position Requirements

Experience, Knowledge and Skills:

• 1+ years of work experience in the medical device industry.
• Experience with ISO 13485, and FDA 21 CFR part 820.
• Proficient computer skills (MS Office, Excel).
• Good verbal and written communication skills. Must be detail oriented and able to work independently.

Compensation & Benefits

Salary range: $23.00 - $28.00

• 120 hours of paid time off per year
• 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 8/26/2026

This position is currently accepting applications.