Job Title: Process Development Engineer

Job Description

We are seeking a highly motivated Process Development Engineer to lead and support catheter development initiatives within our contract manufacturing operations. This role is critical to driving process innovation, equipment validation, and product quality in compliance with ISO standards.

Responsibilities

Lead process development activities for catheter manufacturing, including prototyping, scale-up, and transfer to production.Conduct IQ/OQ/PQ validations for manufacturing equipment and ensure compliance with regulatory standards.Develop and validate test methods to ensure product performance and reliability.Perform process characterizations using statistical tools and methodologies.Utilize Minitab for data analysis, DOE, SPC, and capability studies.Collaborate with cross-functional teams to optimize manufacturing processes and improve yield and efficiency.Support and troubleshoot inspection equipment and ensure proper calibration and functionality.Document and maintain technical reports, protocols, and validation documentation.Contribute to injection molding and extrusion process development as needed.

Essential Skills

Medical device/catheter work historyProcess development of equipmentConsole device work historyManufacturing engineeringProcess improvementProcess engineeringContinuous improvementLean manufacturingSix sigmaProject managementIQ/OQTest methodologiesValidation and verificationEquipment validationEquipment manufacturing

Additional Skills & Qualifications

Bachelor’s degree in Engineering (Mechanical, Biomedical, or related field)3+ years of experience in medical device manufacturing, preferably in catheter developmentStrong knowledge of statistical analysis and Minitab softwareHands-on experience with IQ/OQ/PQ, test method validation, and process characterizationFamiliarity with inspection equipment and quality control toolsExcellent communication skills and a strong work ethicJob Type & Location

This is a Permanent position based out of Maple Grove, MN.

Pay and Benefits

The pay range for this position is $110000.00 - $150000.00/yr.

robust health insurance (medical, dental, vision, mental health, EAP), financial wellness (401k with match, HSA options), generous paid time off (PTO, sick, personal days), and perks like free therapy (Talkspace), employee discounts, and a positive, fun culture and quartile events

Workplace Type

This is a fully onsite position in Maple Grove,MN.

Application Deadline

This position is anticipated to close on Feb 13, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.