Staff Engineer, Design Quality

Description

Summary :

Ensure Product Development & Design Control Processes meet quality and regulatory requirements. Partner with cross-functional peers to identify opportunities and improve development processes and behaviors within the business.

Ensure that all new product development and design change projects are executed in compliance with applicable external regulations, standards, and BD quality management system requirements.

Including but not limited to : Collaborating in Design and Development Planning. Facilitating execution of Design FMEA for complex systems.

Ensuring adequate scope and content of Design Reviews. Authoring Module and Component level Design Verification Plans and Reports.

Building and maintaining end-to-end Design Control Traceability Matrices. Ensuring perfect interconnection between Design & Production / Process Controls and ISO 14971 Risk Management.

Leading root cause investigations into product issues discovered during testing or through other means. Act as a CORE team member representing Quality on new product development and design change projects.

Support internal and external audits and their corrective actions as required. Hybrid in-office / remote position.

Qualifications :

Bachelor’s degree in Engineering (any) or related field of study and five (5) years of experience in the job offered or related occupation in which the required experience was gained.

• Must also have demonstrated experience in the following : Product development and design controls (Design and Development Planning, User Needs, Design Inputs, Design Outputs, Design Verification and Design Validation);
• Risk Management techniques (ISO 14971 and FMEA’s); Technical problem-solving techniques using DMAIC and 8D; Statistical Analysis Software, including Minitab;

and Root cause investigations into product issues discovered during testing.

Primary Work Location :

10020 Pacific Mesa Blvd., San Diego, CA 92121

Hybrid in-office / remote position.

Additional Locations :

N / A

Work Shift : Not Specified

Not Specified

To apply mail resume to Becton, Dickinson and Company, Attn : BDHR DT, 3750 Torrey View Ct, San Diego, CA 92130, OR submit a resume to , OR submit a resume to .

Must reference Job Title & Job Code : R-496078.

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.