Process Development Engineer (6-Month Contract)

Key Responsibilities: 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.

Qualifications: 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.

Preferred Qualifications: 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. Working Conditions and What We OfferOnsite 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. Eligibility to work in the U.S. is required.