Process Development Engineer

Actalent; Saint Paul (MN); On-site; USD 100,000 - 117,000; Full time

Benefits offered by this job

Bonus potential

Job summary

Actalent is seeking a Process Development Engineer in Saint Paul, MN to design and optimize robust manufacturing processes for medical devices with emphasis on catheter products. You will lead process development, validation, and cross-functional collaboration to ensure successful commercialization and transfer to production.

The role requires hands-on manufacturing experience, strong statistical analysis skills, and leadership in continuous improvement across sites, with travel between Fridley

Qualifications

• Bachelor's degree in Engineering or related technical field strongly preferred.
• 5+ years in engineering, manufacturing, or process development; exceptions for advanced degrees.
• Proven knowledge of Process Development Engineering and data-driven decisions.

Responsibilities

• Lead design, development, and validation of manufacturing processes for medical devices, esp. catheters.
• Provide technical leadership for commercial product transfers to production.
• Develop and document robust processes for smooth product introductions to manufacturing.
• Execute process design, development, validation, and optimization activities.
• Apply DOE, pFMEA, DFM, and statistics for data-driven decisions.
• Use process validation methods including installation qualification and studies.
• Lead tooling and equipment projects from selection to qualification for production.
• Analyze complex data and support process selection with statistics.
• Communicate project workstreams to engineering, production, and stakeholders.
• Explain technical concepts to senior management, staff, and customers.
• Build cross-functional relationships and drive continuous improvement.
• Mentor engineers and foster a culture of learning and collaboration.
• Collaborate with technicians on the production floor to resolve issues.
• Coordinate regional/multi-site best practices sharing.

Skills

Process Development

Statistical analysis

Design of Experiments

Cross-functional collaboration

Project leadership

Manufacturing processes

Education

Bachelor's degree in Engineering

Tools

pFMEA

DFM

DOE

Minitab

Job description

Job Description

The 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.

Job Description

The 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 & Location

This is a Permanent position based out of Saint Paul, MN.

Pay And Benefits

The 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 & Location

This is a Permanent position based out of Saint Paul, MN.

Application Deadline

This position is anticipated to close on Nov 19, 2026.

Workplace Type

This 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.

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 process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.