Job Description Summary

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

Job Description

Key Responsibilities:

• 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 engineeringprinciples; analyze results, make recommendations and develop reports.

• Own and close complaint Engineering investigations for BD electronic complaints.

• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. find opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

• Develop, update, and maintain technical content of risk management files for NPD and existing products.

• Develop training and documentation materials for production (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes.

• Support product upgrading and reworking tasks as needed as Quality Engineer.

• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.

• Train, coach, and guide lower-level employees on routine procedures

• Other incidental duties assigned by Leadership

Education and Experience:

• Bachelor's Degree in Engineering or Scientific field

• Minimum of 8 years experience, including strong electromechanical medical device experience

• CAPA and complaints management experience required

• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills

• Strict attention to detail

Preferred Qualifications:

• ASQ Certified Quality Engineer (CQE)

• Considers the cause and effect of activities

• Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment.

• Determines or effectively recommends course of action after considering potential risks of alternatives by comparing and evaluating possible courses of action after considering various possibilities

• Works independently without close supervision

• Applies their knowledge in following procedures or in determining procedures to follow or determining whether specified standards are met

• Proven expertise in usage of MS Office Suite

• Ability to read and interpret drawings

• Proven expertise in statistical techniques

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

• Recognized as an expert in own area within the organization

• Expert knowledge and understanding and knowledge ofprinciples, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)

•  Expertise of Six Sigma concepts with the ability to lead projects applying theseprinciples

• Expertise in applying Quality Engineering concepts (e.g., CQE body of knowledge) with the ability to lead projects using theseprinciples

• Advanced problem-solving, organizational, analytical and critical thinking skills

• Expert understanding of processes and equipment used in assigned work

• Strong leadership skills and ability to influence change and challenge status quo with respect to opportunities for improvement.

• Ability to interact professionally with all organizational levels.

• Ability to manage competing priorities in a fast paced environment

Required Skills

Optional Skills

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Primary Work Location

USA CA - Irvine Laguna Canyon

Additional Locations

Work Shift

NA (United States of America)

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$124,700.00 - $205,800.00 USD Annual