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Process Development Engineer
- Posted: 17/03/2025
- Salary: -
- Location: Osseo, Minnesota, United States
- Job Type: Contract
Senior Process Development Engineer
The Senior Process Development Engineer is responsible for ensuring the successful delivery of high-quality medical products to our customers by driving critical process development projects from varying stages of the product lifecycle. The Process Development Engineer will focus on developing, qualifying, and validating manufacturing processes and equipment, as well as supporting the introduction of new products for contract manufacturing clients.
Success in this role will be highly reliant on the development, validation, and optimization of manufacturing processes to meet both our client’s requirements and regulatory standards. Due to the dynamic nature of the work environment, this position requires on-site presence to manage and oversee project execution.
Principal Responsibilities:
Required Education, Experience, and Qualifications:
The Senior Process Development Engineer is responsible for ensuring the successful delivery of high-quality medical products to our customers by driving critical process development projects from varying stages of the product lifecycle. The Process Development Engineer will focus on developing, qualifying, and validating manufacturing processes and equipment, as well as supporting the introduction of new products for contract manufacturing clients.
Success in this role will be highly reliant on the development, validation, and optimization of manufacturing processes to meet both our client’s requirements and regulatory standards. Due to the dynamic nature of the work environment, this position requires on-site presence to manage and oversee project execution.
Principal Responsibilities:
- Collaborate with Clients: Partner with clients to define the requirements for new and existing manufacturing processes, including equipment and fixture specifications, to support the development and commercialization of medical devices.
- Design of Experiments (DOE): Plan and execute multi-factor design of experiments (DOE) using statistical software to optimize manufacturing processes.
- Process Development: Work closely with the Operations team to develop, improve, and scale new and existing manufacturing processes, ensuring efficiency and compliance with industry standards.
- Equipment Qualification: Conduct equipment qualifications (IQ, OQ, PQ) and support the validation of manufacturing processes for both new and existing client products.
- Process Flow and Documentation: Develop high-level and detailed process flow charts for equipment, fixtures, and manufacturing processes; support creation of work instructions and pFMEA documentation.
- Design and Development: Design, develop, document, and qualify fixtures and equipment using SolidWorks for use in manufacturing operations.
- Technical Reporting: Write complex technical reports based on laboratory experimentation, process development, and equipment qualification activities.
- Cross-Functional Collaboration: Work cooperatively with quality, manufacturing, regulatory, and client teams to ensure smooth project execution and meet customer expectations.
Required Education, Experience, and Qualifications:
- Education: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field
- Experience: At least 5 years of process development or product development experience in a contract manufacturing environment or similar industry.
- Medical Device Experience: Significant experience in developing manufacturing processes for medical devices, especially in a contract manufacturing setting.
- Process Development Expertise: Proven ability to develop new processes and improve legacy manufacturing processes.
- Process Documentation Skills: Proficiency in creating detailed process documentation (e.g., process flow charts, pFMEA, protocols, reports, IQ, OQ, PQ, PPQ).
- SolidWorks Proficiency: Experience with designing, building, and documenting fixtures and equipment for production use in SolidWorks.
- Documentation: Ability to complete detailed process development documentation efficiently and accurately
- Technical Writing & Communication: Superior technical writing skills and clear communication across teams and with customers.
- Team Player: Ability to collaborate effectively in a cross-functional team environment.
- Cross-functional Collaboration: Experience working with teams in Quality, Regulatory, and Operations, to drive product development.
- Data-Driven Decision Making: Knowledge of advanced statistical concepts (e.g., GR&R, DOE, ANOVA) to guide process improvements.
- Design for Manufacturability: Expertise in Design for Manufacturing (DFM) and Design for Assembly (DFA) principles.