Lead Advanced Manufacturing Engineer

Hologic•Louisville, KY

About The Position

This position is responsible for leading the development, qualification, and transfer of manufacturing processes for new products. The Lead Advanced Manufacturing Engineer will possess excellent technical judgment and a deep understanding of design for manufacturability. The candidate may be asked to perform other function-related activities as reasonably required by business needs. This role involves strategic supervision and some guidance with assignments given in terms of broad general objectives and limits.

Requirements

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 criteria to perform a task or sequence of tasks for projects with highly complex features.
Strong technical writing ability, able to independently author process development reports, validation protocols and reports, work instructions, and risk documentation.
Relied upon for thorough review of documentation, including department procedures.
Deep knowledge of manufacturing processes used for handheld surgical instruments and disposables (e.g., injection molding, machining, metal forming, extrusion, common joining methods including welding and adhesive bonding, and rapid prototyping).
Deep knowledge of tooling and fixture design, including mold and assembly fixture specification.
Proficient with design transfer and process validation: IQ/OQ/PQ, process capability (Cp/Cpk), measurement system analysis, and sampling plan rationale.
Proficient with process risk and control tools.
Strong experimental, computational, and analytical skills such as DFSS tools, statistical methods including design of experiments (DOE) and MiniTab.
Proficient with tolerance stack ups, DFM, and GD&T.
Expert using CAD – SolidWorks preferred.
Working knowledge of Lean Six Sigma methods.
Keep informed of new methods and developments affecting the organization and recommend new practices or changes.

Responsibilities

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.