• Process Development Engineer

    Actalent (Maple Grove, MN)


    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

    + 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.

    Additional Skills & Qualifications

    + Bachelor’s degree in Engineering (Mechanical, Biomedical, or related field).

    + Experience in process improvement, process engineering, continuous improvement, lean manufacturing, and Six Sigma.

    + Proficiency in project management and equipment validation.

    Work Environment

    The position is based in a brand-new facility in the Maple Grove Arber Lakes area, equipped with state-of-the-art equipment and processes. The environment encourages collaboration and growth, providing ample opportunities for professional development.

     

    Job Type & Location

     

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

    Pay and Benefits

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

     

    - Employer subsidized health insurance for employees- Employer paid dental insurance- Employer HSA contribution- 401k plan with a company match- 9 paid holidays (including your birthday!) + PTO and Personal days- Gym membership subsidy- Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance

     

    Workplace Type

     

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

     

    Application Deadline

     

    This position is anticipated to close on Nov 5, 2025.

    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.