Job Description Summary

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Job Description Summary:

Manage, mentor, and develop Quality Engineers on approach to design controls, agile design, risk management and product security. Build strong partnerships with cross-functional leaders to drive continuous improvement efforts, through facilitating, leading, and collaborating effectively. Manage and monitor day to day activities to ensure compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.). Quality support of US and OUS sites. Manage quality metrics and present them in management reviews. Responsible to assigned or being the prime quality representative for design control projects – new product development as well as sustaining efforts. Review and/or approval of design history file documentation in support of design controls. Manage all quality aspects of the design control process: quality planning; requirements generation and traceability, code reviews, integration testing, verification and validation planning and execution; risk management; regulatory, compliance and product security support. Lead the defect tracking process and management of issues prior to release and any issues that may present from the post-market surveillance teams. Quality representative in risk management activities including approval of risk management reports and risk analyses. Work closely with Program Management to ensure design deliverables are met and can be released to limited commercial and/or general release. Work together with SW Quality Engineers and SW Quality Managers to ensure effective verification of design specifications and/or requirements. Review effectiveness of assessments of DHFs and Change Orders and/or Electronic Release Authorizations for new releases or design enhancements. Active participant in the development of product requirement, product system hazard analysis and design reviews. Work closely with Product Management and UX teams to ensure effective validation of user needs. Ensure product technical files and Design History Files are complete, traceable and auditable. Provide clarification and guidance to teams on overall quality system with emphasis in design controls. Provide decisions, recommendations, and results to further the achievement of goals critical to organizational objectives. Identify areas requiring quality improvement and initiate and follows through plans of action (Quality Plans) necessary for implementation. Responsible to provide Quality support in 510k or International submissions as warranted. Successful completion of major programs/initiatives and may function in a project leadership role.

Qualifications:

Master’s degree in Engineering (any), Life Sciences or related field of study and eight (8) years of experience in the job offered or related occupation in which the required experience was gained. In lieu of a Master’s degree in Engineering (any), Life Sciences or related field of study and eight (8) years of experience, the employer will also accept a Bachelor’s degree in Engineering (any), Engineering (any), Life Sciences or related field of study and ten (10) years of experience in the job offered or related occupation in which the required experience was gained. Must have demonstrated experience with: Regulatory requirements (cGMP, FDA or ISO); Design controls and risk management methodologies; Agile methodologies and software development life cycle; Quality principles (ISO 13485, IEC 62304, IEC 14971 or 21 CFR) to the R&D environment; cybersecurity design considerations; and software development life cycle and test methodology.

Salary offered for the position is: $192,958.87 - $261,100.00/year.

Primary Work Location:

10020 Pacific Mesa Blvd., San Diego, CA 92121

Additional Locations:

N/A

Work Shift:

Not Specified

To apply, submit a resume to https://bdx.wd1.myworkdayjobs.com/EXTERNAL_CAREER_SITE_USA, OR mail resume to Becton, Dickinson and Company, Attn: BDHR – DT, 3750 Torrey View Ct, San Diego, CA 92130, OR submit a resume to https://www.caljobs.ca.gov/vosnet/Default.aspx. Must reference Job Title & Job Code: R-539103. EOE.

#DNPBD

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. 

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Required Skills

Optional Skills

.

Primary Work Location

USA CA - San Diego Bldg A&B

Additional Locations

Work Shift

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

$158,300.00 - $261,100.00