Job Description The Sr. Quality Engineer role 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 , 4 years experience including either industry or industry/education Required or Master's Degree or equivalent in in Engineering or Scientific field , 2 years experience including either industry or industry/education Required or Ph.D. or equivalent in in Engineering or Scientific field , 1 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 in a fast paced environment - Work is performed independently while exercising considerable latitude in making significant decisions - Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts - Represents organization in providing solutions to difficult technical issues associated with specific projects - Develops technical solutions to complex problems which require the regular use of creativity - Uses best practices and knowledge of internal or external business issues to improve products/services or processes - Typically resolves complex problems or problems where precedent may not exist - Travel Requirements: % not specified, but travel has occurred in the past on an as-needed basis for project continuity Primary Work Location USA CA - Irvine Laguna Canyon Additional Locations Work Shift At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. Salary Range Information $105,500.00 - $168,800.00 USD Annual