Sr. Staff Quality Engineer, Risk Management

Job Description Summary

The Sr. Staff Engineer is responsible for leading and managing all quality activities related to design and development (including risk management) and transfer of medical devices to manufacturing.
They will lead multi-functional teams during the design and development and post-market phase to ensure that all necessary design control and post-market activities are driven in accordance with the quality system.

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.

Responsibilities

Primary responsibilities include but are not limited to:

• Collaborate on software design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements.
• Ensure cybersecurity are integrated into product design, reviewing software artifacts for compliance and traceability.
• Engage in design and development activities for both medical and non-medical
• Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Design Quality Engineer members that share in varying pieces of the risk management lifecycle
• Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.
• Find opportunities for continuous improvement of the Design Control (including Risk Management) Process

Basic Qualifications:

• Bachelor's degree in engineering field and 10 years of Quality, Design Controls, Risk Management, or Software experience within the medical device industry
• Working knowledge of IEC 62304 and AAMI TIR57
• Advanced knowledge of risk management, design controls, regulatory, quality engineering polices, principles and standard methodologies
• Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software verification/validation.
• Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including ISO 14971, ISO 62304, TIR 57, IEC 62366, 21 CFR 820.30, HE 75, Human Factors.
• The position requires strong oral and written communication and interpersonal skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA CA - San Diego TC Bldg C&D

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
$155,900.00 - $257,300.00 USD Annual