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Position Overview: We are seeking a Quality Engineering technical lead in the development of new products, primarily class I, class II & class III single-use and re-usable medical devices by ensuring compliance with contractual and regulatory requirements. This individual will work closely with our New Product Innovation (NPI) QE team, contract manufacturers, and quality control to ensure that only good products are shipped out.

Key Responsibilities:

• Assessing incoming inspection methods and sampling, process controls at the contract manufacturers or for vertically integrated work cells, facilitating nonconforming material report investigation and closure, failure investigations, CAPA and SCAR ownership, and change control activities

• Liaising with R&D, Manufacturing, Supplier Quality, Supply Chain, and other Operational supporting staff. Including a close collaboration with our Regulatory Team, for both New Product Innovation and continuous improvement projects

• Assess and implement effective incoming inspection methods and sampling strategies

• Collaborate with contract/internal manufacturing to ensure adherence to regulatory requirements

• Investigate and resolve nonconforming material reports in a timely manner

• Conduct failure investigations and implement corrective actions

• Liaise with cross-functional teams to drive continuous improvement initiatives

• Must be able to travel up to 10% of the time
  

Qualifications:

• Minimum bachelor's degree (BS) from a four-Year College or university in Mechanical, Industrial or Systems, Biomedical, or Manufacturing Engineering.

• 4+ years related experience and/ or training; or equivalent combination of education and experience.

• Knowledge of both US and International medical device quality system requirements (e.g. 21 CFR Part 820, ISO 13485), and other applicable standards.

• Experience supporting on-market / commercialized product

• Knowledge of mechanical inspection methods and equipment

• Knowledge of SPC, DOE, probability, and statistics

• Ability to read, analyze, and interpret blueprints and GD&T

• Ability to solve complex problems to root cause and prevent re-occurrence (CAPA)

• Ability to write reports and procedures

• Ability to effectively interact with all levels of the organization

• Ability to develop and maintain strong working relationships with internal and external customers and suppliers

• Knowledge of SolidWorks or other CAD software desirable.

• Detail Oriented

• Good decision-making skills and judgment

• The ability to execute plans/strategies to completion

• Working knowledge of biocompatibility requirements