Staff QE, Risk Management – SW & Cyber

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most exciting global health issues.

The Staff Quality Risk Management Engineer is responsible for planning, coordination and execution of Risk Management activities for products in design & development. This position will work closely with cross-functional development teams to create and execute the risk management strategy, processes, and deliverables throughout the design and development process across BD products. They will apply a risk-based approach throughout the development phases of infusion pumps and supporting products, and facilitate the risk management deliverables to support regulatory filings, product launch, and post-market surveillance risk management framework.

Responsibilities

Primary responsibilities include but are not limited to:

  • Collaborate with engineering, design, commercial, and product teams to ensure that all hazards associated with medical device software and cybersecurity are identified, the associated risks are estimated, evaluated, controlled and documented; and monitors that the risk controls are implemented, verified, and validated for the entire product lifecycle.
  • Plan and execute the management of risk for medical device projects involving software and cybersecurity to ensure that risk management is performed efficiently and in sufficient detail in support of new product development.
  • Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members that share in varying pieces of the risk management lifecycle
  • Find opportunities for continuous improvement of the Risk Management Process

Basic Qualifications:

  • Bachelor’s degree in software related field and 6-9 years of Quality, Design Controls, Risk Management, or Software experience within the medical device industry
  • Working knowledge of ISO 62304 and AAMI TIR57
  • Advanced knowledge of risk management, regulatory, quality engineering polices, principles and standard methodologies
  • Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including: ISO 14971, 21 CFR 820.30
  • 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

For many 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, weekly testing for COVID-19 may be available instead of vaccination. 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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

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

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action 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.

PDN

Primary Work Location

USA CA – San Diego TC Bldg C&D

Additional Locations

Work Shift

Job IDR-423904

Date posted – 01/24/2022

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