Senior / Principal Process Development Engineer

• Lead process development, scale-up, optimization, and manufacturing transfer activities for biomaterial and medical device manufacturing processes.
• Design and execute laboratory, pilot-scale, and production-scale studies to establish process windows, identify critical process parameters, and improve process robustness, yield, throughput, and product quality.
• Apply design of experiments, statistical analysis, and structured data review to evaluate process performance, understand sources of variation, and support data-driven process decisions.
• Develop process flow diagrams, process descriptions, engineering study protocols, technical reports, risk assessments, and process control strategies suitable for quality system and regulatory use.
• Evaluate manufacturing equipment, tooling, fixtures, automation options, utilities, and supporting technologies; define user requirements, compare vendor options, and make clear purchase recommendations based on technical fit, scalability, quality requirements, cost, lead time, and maintainability.
• Partner with equipment vendors and internal stakeholders to support equipment specification, procurement, installation, commissioning, qualification, and readiness for routine use.
• Support process validation strategy and execution, including development of validation plans, protocols, acceptance criteria, sampling plans, data analysis, deviations, final reports, and ongoing process monitoring.
• Troubleshoot manufacturing and process performance issues using root cause analysis, structured experimentation, and cross-functional technical review.
• Collaborate with quality and regulatory teams to ensure process development, scale-up, equipment qualification, and validation activities align with GMP, ISO 13485, and applicable medical device quality system expectations.
• Train and mentor manufacturing, engineering, and technical staff on process requirements, equipment operation, process controls, and documentation expectations.
• Support supplier and material changes, manufacturing deviations, nonconformances, CAPAs, change controls, and continuous improvement initiatives as needed.

• Hands-on experience developing, scaling, optimizing, and validating manufacturing processes for polymeric materials, biomaterials, medical devices, pharmaceuticals, or other regulated products.

• BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, Polymer Science, or related engineering discipline; advanced degree desirable for Principal level.
• Senior level: 5+ years of relevant hands-on process development, scale-up, manufacturing engineering, or process validation experience. Principal level: 8+ years of relevant experience with demonstrated leadership of complex process development, scale-up, equipment selection, and validation programs.
• Demonstrated experience using DOE, statistical data analysis, process capability concepts, and structured experimental design to optimize and characterize manufacturing processes.
• Experience defining process parameters, acceptance criteria, sampling plans, and validation approaches for regulated manufacturing processes.
• Experience evaluating and specifying manufacturing equipment, working with vendors, developing user requirements, supporting purchase recommendations, and supporting equipment qualification or commissioning activities.
• Working knowledge of GMP, ISO 13485, process validation, equipment qualification, change control, deviation investigation, and documentation expectations for regulated product manufacturing.
• Strong technical writing skills with experience generating protocols, engineering reports, validation documentation, process descriptions, risk assessments, and manufacturing procedures.
• Self-starter with strong organizational, problem-solving, and prioritization skills; able to work independently, manage multiple technical workstreams, and lead cross-functional initiatives in a fast-paced regulated environment.

• Specific experience with polymer milling, particle size reduction, powder or particulate handling, sieving/classification, milling equipment selection, and scale-up of polymer processing operations is strongly preferred.
• Experience with biomaterials, implantable medical devices, injectable or soft-tissue products, resorbable polymers, or other polymer-based regulated products.
• Experience transferring processes from R&D into GMP manufacturing, including development of work instructions, batch records, in-process controls, equipment settings, and operator training materials.
• Experience with statistical software, process monitoring tools, or data analysis platforms used for DOE analysis, process characterization, capability assessment, and validation reporting.
• Prior involvement supporting regulatory submissions, audits, inspections, or technical responses related to manufacturing processes, equipment qualification, or validation.
• Leadership experience mentoring engineers, technicians, or manufacturing personnel; stronger emphasis on technical leadership and program ownership for Principal level.

• Onsite presence required for laboratory, pilot-scale, manufacturing, and equipment-related activities with occasional travel to vendors or external partners.
• Fast-paced, collaborative environment balancing development, scale-up, validation, equipment readiness, and manufacturing support activities.
• Competitive compensation, benefits, and professional development opportunities.
• Opportunity to shape process scale-up and manufacturing strategy for an innovative biomaterials platform with clear patient impact.

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