Principal Engineer, Quality - Critical Care

BD recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care division, and as such, will become a part of the BD organization in the future. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com  

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

This Principal Quality Engineer will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and quality systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

How You Will Make an Impact:

• Leads design assurance and development activities (i.e., requirement development, risk assessment, engineering study, feasibility testing, drawing review, etc.) for New Product Development programs

• Provides engineering solutions in the areas of Quality Assurance, Design Control, Risk Management, and Statistical Techniques.

• Develop, update, and maintain technical content of risk management files

• Collaborates cross-functionally (eg. R&D, Mfg/Ops, Regulatory) to help facilitate the successful execution of the NPD process and launching of robust products

• Develop and validate complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.

• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.

• Lead identification, development, and optimization of design verification activities and complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for design for manufacturing and continuous process improvement initiatives. Identify opportunities & implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc. to

• Assigns tasks; gives instruction to technicians on conducting tests; trains technicians and less seasoned engineers and provides feedback; and may coordinate engineer work.

• Other incidental duties assigned by Leadership

What You’ll Need (Required Qualifications):

• Bachelor's Degree in in Engineering or Scientific field , 6 years experience including either industry or industry/education Required or

• Master's Degree or equivalent in in Engineering or Scientific field, 5 years experience including either industry or industry/education Required or

• Ph.D. or equivalent in in Engineering or Scientific field, 2 years experience including either industry or industry/education Required

• Hands-on experience with Design Assurance, including Design Controls, Design Freeze (or pre-design testing), Design Verification & Validation, and/or Design Test Method Development

• Experience working within a highly regulated industry

What Else We Look For (Preferred):

• Knowledge of and experience with Risk Management/Usability Engineering and authoring risk management documents.

• Demonstrated technical leadership (i.e., solving complex problems; implementing a process or Quality improvement; piloting/creating new methodologies)

• In-depth working knowledge and understanding of statistical techniques

• Ability to read and interpret drawings

• Ability to translate technical information to all levels of the organizations

• Test Method Development and Validation Experience

• Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)

• Knowledgeable with MDR regulations

• Strong technical writing skills

• Ability to manage competing priorities