Process Development Engineer III

ResponsibilitiesParticipate in the development of combination medical products for clinical trials and commercial production in accordance with 21CFR part 210/211 and 820.Planning and guides the development, implementation and maintenance of manufacturing methods, processes, and operations for new and existing products.Evaluates, selects, and orders equipment that is most appropriate and cost effective for the manufacture of company products.Leads and participates in the generation of product, component, assembly, and machine specifications, drawings, test protocols and reports.Oversees the installation, modification, upgrade and maintenance of manufacturing equipment. Studies equipment performance and reliability.Establishes programs and solutions for increasing uptime and for equipment problems that affect the manufacturing process.Develops and establishes maintenance requirements for production equipment.Develops and executes manufacturing instructions, validation protocols, and testing strategies for production equipment.Acts as a liaison to design engineering functions in developing and releasing new products.Manages and executes change protocols and requests for cGMP materials and equipment.Documents development efforts in the form of reports.Develops spares parts list for all production equipment and works with purchasing department in the ordering of spares parts.Able to perform failure analysis using pFMEA, root cause analysis and other problem solving techniques.Creates and executes IQ, OQ, PQ, and writes reports for custom equipment and tooling.Acts as manufacturing liaison with material suppliers and contract manufacturers.Provides daily production support on the day-to-day production activities.Work with production personnel to continually find opportunities for reducing cycle time, improving processes and increase yields while improving product cost.Skills requiredExperience with design and development of combination products or equivalent.Excellent interpersonal and communication skills to allow effective participation in project teamsStrong documentation skillsUnderstanding of current Good Manufacturing Practices (cGMP), Quality System Regulations (QSR) including design control.Must be able to handle multiple priorities and work across multidisciplinary, multi-organizational, teams consisting of chemists, electrical and mechanical engineers.Self-starter with strong problem-solving skillsAbility to work on multiple projects in a fast-paced, start-up environment with milestone driven time lines.Acts independently to plan for new assignments. May oversee activities of lower-level personnelWorks on complex issues requiring imaginative solutions based on analysis of data from various factors.Exercises judgment in selecting methods, techniques and evaluation criteria for solving problems. Decisions have internal and external impact.Education and experienceB.S. or M.S. in Mechanical, Chemical or Materials Engineering with, 6-8 years of Design and/or Manufacturing Engineering experience.Ph.D. in Mechanical, Chemical or Materials Engineering with 4-6 years of Design and/or Manufacturing Engineering experience.Familiar with the definition and execution of DOEs to determine the impact of independent variables on processes and designs.Familiar with risk based design and process control methodologies utilizing tools like FMEAs or FTA.Experienced in the use of Pharmaceutical Quality by Design and Design for Manufacturability (DFM) approaches during scale-up and definition of commercial processes.Familiar with validating processes and or designs and the regulatory expectations associated with these activities. Experienced with the manufacture of cGMP-regulated pharmaceuticals or QSR regulated medical devices.Knowledge on the use of statistical methods to demonstrate process and design robustness.Familiarity with six sigma methodologies and design software a plus.Physical RequirementsProlonged periods of sitting at a desk and working on a computerMust be able to lift up to 15 pounds at timesMust be able to travel

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