Lead Advanced Manufacturing Engineer

Lead Advanced Manufacturing Engineer possessing excellent technical judgment and a deep understanding of design for manufacturability to lead the development, qualification, and transfer of manufacturing processes for new products.

Essential Duties and Responsibilities: The candidate may be asked to perform other function-related activities in addition to the below mentioned as responsibilities as reasonably required by business needs.

This position is responsible for performing the following tasks as assigned while receiving strategic supervision and some guidance with assignments given in terms of broad general objectives and limits:

Technically leads advanced manufacturing engineering for large, complex projects, including the manufacturing strategy, process architecture, and design transfer plan across multiple subsystems, while managing short & long term deliverables to meet project milestones. Liaison between the Product Development and Manufacturing teams Leads design for manufacturability, assembly, and inspection (DFM/DFA/DFI) reviews with R&D, and drives manufacturability, capability, and cost requirements into the product design. Develops and qualifies manufacturing processes, tooling, and fixtures for new products, from feasibility through pilot builds to production release. Leading technical project meetings and making presentations to support technical decisions. Routinely interacts with project teams, suppliers, customers, contractors, and others. Works closely with Sourcing and Supplier Quality on supplier selection Prepares and reviews scopes, budgets, and schedules for assignments and projects. Leads and/or directs pilot builds, design transfer, process validation (IQ/OQ/PQ), process capability studies, and measurement system analysis (MSA). Applies broad knowledge of risk management tools, including process FMEA and control plans, to identify, assess, and mitigate process risks throughout the entire product lifecycle. Formulates and solves problems that require significant depth of technical knowledge and/or skillset. Applies broad knowledge of principles and practices in multiple practice areas to solve complex problems. Prepares complete project documents, including process development reports, validation protocols and reports, and manufacturing procedures. Reviews complete project documents for conformity and quality assurance. Researches new techniques, manufacturing technologies, and theories in related fields to help support completion of assignments. Collaborating cross-functionally to develop methods and processes that facilitate decisions and improve results. Assists upper-level management and staff as a technical specialist or advisor on manufacturability, process capability, and manufacturing cost. Effectively communicates to cross-functional teams to drive the best decisions for the business. Active role in mentoring and developing other engineers. Reviews operational procedures to ensure compliance with applicable policies and performance measures.

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Qualifications Education:

Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related field with manufacturing or process development experience in the medical device industry

8 years of work experience in the health and/or business communities with Bachelor’s Degree 6 years of work experience in the health and/or business communities with Master’s Degree

Action and detail oriented with an aptitude for technical learning Fast and accurate communication to team members and management Strong functional and technical skills, problem solving skills and a drive for results Apply knowledge and expertise acquired through progressive experience to develop teams, resolve crucial issues, and/or unique conditions. Evaluate, select, and apply standard techniques, procedures, and