"Alerted.org

Job Title: Process Development EngineerJob 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 history

+ Process development of equipment

+ Console device work history

+ Manufacturing engineering

+ Process improvement

+ Process engineering

+ Continuous improvement

+ Lean manufacturing

+ Six sigma

+ Project management

+ IQ/OQ

+ Test methodologies

+ Validation and verification

+ Equipment validation

+ Equipment 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 development

+ Strong knowledge of statistical analysis and Minitab software

+ Hands-on experience with IQ/OQ/PQ, test method validation, and process characterization

+ Familiarity with inspection equipment and quality control tools

+ Excellent communication skills and a strong work ethic

Work Environment

Our brand new facility in the Arber Lakes area features state-of-the-art equipment and processes, offering ample room for growth and innovation. The environment is collaborative, leveraging core competencies in medical device product design and development through manufacturing.

Job 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 Jan 30, 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 [email protected] (%[email protected]) for other accommodation options.