Principal Manufacturing Engineer

3 weeks ago

New York, United States Imperative Care Full time

What You’ll Do The Principal Manufacturing Engineer will plan and lead projects focused on development and continuous improvement of neuro-interventional medical device manufacturing processes though definition, characterization, optimization and validation resulting in stable, robust and capable sustained commercialization. In this position, the Principal Manufacturing Engineer will lead teams and/or projects to develop, improve and qualify internal equipment and processes and will oversee management and qualification of processes at external suppliers and contract manufacturers. Responsibilities will include strategic creative problem solving and critical thinking and will oversee the planning and execution of DOEs/process characterization studies, analysis, interpretation, and documenting and reporting of data.

Lead collaborative efforts to research, define and develop new manufacturing processes and improve existing processes. Individually or collaboratively initiate and contribute to manufacturing process innovation by identifying and selecting new process technologies. Lead aspects/individuals to develop, document and qualify new or improve existing equipment and fixturing. Lead teams in the identification of continuous improvement opportunities, including quantifying opportunity investment cost/ROI. Lead tasks to develop process windows, manufacturing control limits and workmanship standards. Lead projects to define manufacturable product design specifications and visual standards. Lead and mentor the design, execution, test, analysis and interpretation of results from DOEs. Lead and mentor DMAIC principles to make data-driven decisions, solve problems and find root cause. Lead or oversee equipment & process documentation architecture. Collaborate with cross functional teams to develop manufacturing systems and architecture to facilitate efficient workflows, effectivity monitoring control plans, lot history records. Lead cross-functional team members to design, characterize, optimize, document, and control all manufacturing processes through the definition and measurement of critical process parameters (CPP) which impact critical quality attributes (CQA) of the product. Lead and teach analytical techniques and apply engineering principles to understand the impact and interaction of materials and processes on process and product outputs. Provide technical subject matter expertise and oversee management and partnerships with external suppliers by executing due diligence assessments, setting specifications for critical quality and/or manufacturing attributes (CQA, CMA) for materials and components, collaborate on development projects and qualification/validate external processes.

What You’ll Bring BS in Engineering or related discipline and 12+ years of related experience; or MS in Engineering with 8+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry Able to perform/oversee computer modeling simulations to determine the effects of design, materials, and process on the functional and reliability performance of the final product preferred. Experience in pilot and production line set-up, validation and scale-up in a controlled environment. Excellent analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP. Excellent knowledge and experience in FDA Design Control procedures and DFSS/DFM tools. Excellent project management and communications skills (both written and verbal). Agile scrum framework preferred. Exceptional critical thinking – able to intuitively identify problems, logically and empirically associate cause and effect, and under a variety of perspectives and constraints, prioritise and provide creative, effective and practical solutions. Excellent working knowledge and application of DMAIC methodology. Six Sigma Black Belt preferred Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards. Familiar with GMP, GDP procedures and requirements. Ability to work independently or in a team setting and mentor/manage. Ability to travel – as required.

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