Keywords – Medical device manufacturing experience, NPI support, Process validation, IQ/OQ/PQ, Design for Manufacturing (DFM), DFMEA, PFMEA, Risk management

Work closely with operations and the business functions to ensure quality performance of products and processes.

Responsibilities:

• Advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance, quality control and preventative activities.

• Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA.

• Will develop and characterize processes that are capable, scalable and produce high yield.

• Will support the design of robust inspection strategies including CQA’s, CTQ’s and MSA’s to enable process risk identification, process characterization, capability and robust process control.

• Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA).

• Ensure all Risk Management outputs comply with ISO14971

• Provide manufacturing quality engineering support for the execution of quality assurance activities during design transfer phases of new product development.

• Support the required stages defined in the product and process design cycle ensuring compliance with the current design control and transfer regulations and policy.

• Develop Measurement System Analysis (MSA) strategy and approve executed MSAs.

• Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable.

• Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.

• Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis.

• Influence processes towards validation versus manual verification, where possible.

• Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.

• Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies and tooling & fixture development

• Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP).

• Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.