Process Development EngineerJob DescriptionThe Process Development Engineer plays a key role in developing robust, sustainable manufacturing processes for medical components and devices, with a particular focus on catheter products. Working as part of the process development team, this role provides technical leadership for the commercial release of products into production, guiding projects through the full product development process. The position is highly hands-on and involves process design and optimization, data analysis, cross-functional collaboration, customer communication, and thorough documentation. The ideal candidate brings a strong background in catheter product development and demonstrated project technical leadership.Responsibilities
- Lead the design, development, and validation of manufacturing processes for medical devices, with emphasis on catheter-related products.
- Provide technical leadership throughout the product development process to ensure successful commercial release of products to production.
- Develop, implement, maintain, and document robust technical processes that enable the smooth introduction of new products into manufacturing.
- Execute and oversee process design, development, and validation activities, including process characterization and optimization.
- Utilize tools such as Design of Experiments (DOE), pFMEA, Design for Manufacturing (DFM), and statistical analysis to make data-driven decisions and solve complex technical problems.
- Apply process validation methodologies, including installation qualification and engineering studies, to demonstrate sound technical rationale for process and equipment decisions.
- Lead the identification, procurement, and installation of new tooling, fixturing, and equipment, and drive the qualification or verification of these assets for production use.
- Analyze complex data sets and use statistical methods to support process selection decisions and resolve technical challenges.
- Identify, execute, and clearly communicate technical and project workstreams, ensuring alignment across engineering, production, and other stakeholders.
- Communicate complex technical concepts effectively to diverse audiences, including senior management, production employees, and customers.
- Develop and maintain strong cross-functional relationships and influence teams to drive results and continuous improvement.
- Champion continuous improvement initiatives and promote ongoing change to meet evolving company and customer needs.
- Mentor other engineers, provide constructive feedback, and support a culture of learning and collaboration.
- Collaborate closely with technicians and operators on the production floor to troubleshoot and resolve technical issues.
- Establish and maintain regional relationships and collaborate with other sites to share and implement best practices.
- Travel between the White Bear Lake, MN and Fridley, MN locations as needed to support process development and production activities.
- Perform other related duties as assigned to support product development, manufacturing, and organizational goals.
Essential Skills
- Bachelors degree in Engineering or a related technical field strongly preferred; other relevant postsecondary education, training, and experience may be considered in lieu of a degree.
- Minimum of 5 years of relevant experience in engineering, manufacturing, or process development; 1 year of relevant experience may be substituted by a graduate degree and 3 years by a doctorate degree.
- Demonstrated knowledge and practical experience in Process Development Engineering.
- Hands-on experience in manufacturing or process development in one or more areas such as medical devices (delivery systems or catheters), micro-assembly, reflow, laser ablation, laser welding, or laser marking.
- Proven ability to make complex, data-driven decisions using statistical analysis.
- Experience with process validation, including installation qualification and preparation of engineering deliverables within the product development process.
- Strong ability to identify, execute, and communicate technical and project workstreams effectively.
- Excellent communication skills with the ability to convey complex technical concepts to senior management, production staff, and customers.
- Demonstrated ability to build cross-functional relationships and influence others to drive results.
- Leadership capabilities in promoting continuous improvement and change to meet organizational needs.
- Consistent ability to determine solutions for complex problems, make sound process selection decisions, and overcome technical challenges.
- Proficiency in using process characterization tools such as Design of Experiments (DOE), pFMEA, Design for Manufacturing (DFM), and statistics.
- Willingness and ability to travel between Fridley, MN and White Bear Lake, MN sites as needed.
Additional Skills & Qualifications
- background in catheter product development and project technical leadership.
- Experience working with medical device delivery systems and catheter-based technologies.
- Ability to create and leverage process validation protocols and engineering studies to document technical rationale.
- Experience leading new tooling, fixturing, and equipment projects from identification through procurement, installation, and qualification.
- Capability to mentor and support other engineers, fostering a culture of feedback and professional growth.
- Track record of effective collaboration with technicians and operators on the production floor to resolve technical issues.
- Experience establishing regional or multi-site relationships to share and implement best practices.
- Strong organizational skills and attention to detail in coordinating documentation and engineering deliverables.
Job Type & LocationThis is a Permanent position based out of Saint Paul, MN. Pay and BenefitsThe pay range for this position is $100000.00 - $117000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Potential for 10% Bonus 100-117k/year Job Type & LocationThis is a Permanent position based out of Saint Paul, MN. Application DeadlineThis position is anticipated to close on Nov 19, 2026. Workplace TypeThis is a fully onsite position in Saint Paul,MN.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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
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