Process Development Engineer
Actalent
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Benefits offered by this job
Job summary
Actalent in Saint Paul, MN is seeking a Process Development Engineer III to create robust manufacturing processes for medical components and devices, with a primary focus on metals and nitinol. This role provides technical leadership for the commercial release of products into production, ensuring processes are well characterized, validated, and ready for scale.
The engineer will lead moderate-level process design and development activities, mentor other engineers, and collaborate closely with
Qualifications
- Bachelor's degree in engineering or related field.
- Experience with nitinol or stainless-steel manufacturing.
- Data-driven decision making using statistical tools.
- Experience with process validation and IQ/OQ in manufacturing.
- Experience producing finished engineering deliverables for product development.
- Ability to coordinate and communicate across technical teams.
- Ability to convey complex concepts to colleagues across functions.
Responsibilities
- Lead process design, development, and validation for medical devices.
- Develop robust manufacturing processes for metals/nitinol components.
- Apply DOE, pFMEA, DFM and statistics to guide decisions.
- Create validation protocols and technical studies.
- Provide technical leadership for product release to production.
- Mentor engineers and share best practices on the team.
- Collaborate with technicians on the production floor to resolve issues.
- Plan and communicate progress, risks, and results to stakeholders.
- Support CAD/CAM documentation for manufacturing records.
- Ensure regulatory and quality requirements are met.
Skills
Education
Tools
Job description
As a key member of the Process Development team, the Process Development Engineer III will create robust, sustainable manufacturing processes for medical components and devices, with a primary focus on metals and nitinol. This role provides technical leadership for the commercial release of products into production, working cross-functionally through the product development process to ensure processes are well characterized, validated, and ready for scale. The engineer will lead moderate-level process design and development activities, mentor other engineers, and collaborate closely with production teams to solve complex technical challenges.
As a key member of the Process Development team, the Process Development Engineer III will create robust, sustainable manufacturing processes for medical components and devices, with a primary focus on metals and nitinol. This role provides technical leadership for the commercial release of products into production, working cross-functionally through the product development process to ensure processes are well characterized, validated, and ready for scale. The engineer will lead moderate-level process design and development activities, mentor other engineers, and collaborate closely with production teams to solve complex technical challenges.
As a key member of the Process Development team, the Process Development Engineer III will create robust, sustainable manufacturing processes for medical components and devices, with a primary focus on metals and nitinol. This role provides technical leadership for the commercial release of products into production, working cross-functionally through the product development process to ensure processes are well characterized, validated, and ready for scale. The engineer will lead moderate-level process design and development activities, mentor other engineers, and collaborate closely with production teams to solve complex technical challenges.
- Lead and participate in process design, development, and validation activities for medical devices throughout the product development lifecycle.
- Develop robust and sustainable manufacturing processes for metals and nitinol-based medical components and devices, with flexibility to support other departments as needed.
- Demonstrate strong problem-solving skills in determining solutions for complex technical problems, process selection decisions, and manufacturing challenges.
- Use process characterization tools such as Design of Experiments (DOE), process Failure Modes and Effects Analysis (pFMEA), Design for Manufacturability (DFM), and statistical methods to make data-driven decisions.
- Create and leverage technical documentation, including process validation protocols, engineering studies, and other deliverables that clearly support and justify process and design decisions.
- Provide technical leadership for the commercial release of products to production, ensuring processes meet quality, regulatory, and operational requirements.
- Mentor other engineers, share best practices, and promote a culture of constructive feedback and continuous improvement within the team.
- Work collaboratively with technicians and operators on the production floor to troubleshoot and resolve technical issues in real time.
- Identify, plan, and execute technical and project workstreams, and communicate progress, risks, and results clearly to stakeholders.
- Apply knowledge of process validation and installation qualification to ensure manufacturing processes are properly verified and documented.
- Utilize CAD/CAM tools, including 3D modeling and print drafting, to support process development and manufacturing documentation as needed.
- Make effective use of statistical analysis to interpret data, optimize processes, and support decision-making.
- Communicate technical concepts clearly and effectively to colleagues across engineering, production, and other functional areas.
- Perform other related duties as assigned to support process development and product commercialization goals.
- Bachelors degree in Engineering or a related technical field strongly preferred; relevant postsecondary education, training, and experience may be considered in lieu of a degree.
- Exposure to or experience with manufacturing processes involving nitinol or stainless-steel materials.
- Ability to make data-driven decisions using statistical tools and analysis.
- Experience with process validation and installation qualification in a manufacturing or product development environment.
- Experience producing finished engineering deliverables that support the product development process.
- Ability to identify, execute, and communicate clearly on technical and project workstreams.
- Ability to communicate technical concepts effectively to colleagues across different functions and levels.
- Experience with precision manufacturing processes such as laser cutting, shape setting, chemical processing, electropolishing, or similar techniques.
- Experience with CAD/CAM software, including 3D modeling and print drafting, to support process and product development.
This is a Permanent position based out of Saint Paul, MN.
The pay range for this position is $80000.00 - $120000.00/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.
Base salaries are determined by taking a variety of factors into account, including, but not limited to, candidate qualifications, geographic locations, market conditions and internal equity. This position is bonus eligible, with a target bonus of 10%. Our total compensation package includes eligibility for comprehensive medical, dental, and vision coverage, a 401(k) plan with company match, education reimbursement, paid parental leave and paid time off.
This is a Permanent position based out of Saint Paul, MN.
This position is anticipated to close on Nov 5, 2026.
This is a fully onsite position in Saint Paul,MN.
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 actalentaccommodation@actalentservices.com 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.
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