Job Description Summary

The Staff Design Quality Engineer is responsible for quality leadership and support of new product development and technology research projects for Biosciences Instruments and Reagents. This individual will ensure that the design control requirements are implemented and followed, will support multiple product development projects for Biosciences and will ensure that the quality objectives are met during the product development life cycle. This role will be an active mentor and coach to ensure products meet quality standards consistent with both Corporate and Business policies, while meeting all design control and other regulatory requirements. Specifically, this individual will leverage best practices in support of cross functional team leadership to drive excellence in areas such as customer requirement definition, product design and development and commercial launch. The staff quality engineer will ensure a mentality of collaboration, execution and continuous improvement while ensuring effective formal and informal communication mechanisms are employed.

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 Responsibilities:

1. Project Leadership:
- Lead extended quality teams in the planning and execution of new product introduction projects from concept through to commercialization.

2. Product Development:
- Collaborate with R&D, manufacturing, and regulatory affairs to define product specifications and ensure alignment with quality and regulatory requirements.
- Conduct design reviews and provide feedback on design verification and validation activities for both hardware and software components.

3. Software Quality and Risk Management:
- Oversee the software development lifecycle, ensuring compliance with industry standards (e.g., IEC 62304) and best practices in software quality management.
- Support Product Security Officer to Identify and assess cybersecurity risks related to new products, implementing necessary controls and mitigation strategies to protect patient data and ensure product integrity.

4. Regulatory Compliance:
- Ensure that all new products align with relevant regulations (e.g., FDA, ISO 13485, IVDR) and work closely with regulatory affairs to prepare and submit necessary documentation.

5. Risk Assessment and Management:
- Conduct risk assessments (e.g., FMEA, ISO 14971) throughout the product development process to identify potential risks and implement appropriate mitigation strategies.
- Monitor and address any quality issues that arise during the NPI process, employing root cause analysis and corrective action planning as necessary.

6. Continuous Improvement:
- Drive continuous improvement initiatives in the NPI process, leveraging lessons learned and industry best practices to enhance product quality and efficiency.
- Mentor and train junior engineers and team members on NPI processes, software validation, and cybersecurity risk management.

7. Stakeholder Communication:
- Serve as the primary point of contact for stakeholders regarding NPI projects, providing regular updates on progress, challenges, and milestones.
- Facilitate effective communication and collaboration among cross-functional teams to ensure alignment and resolve issues promptly.

Education and Experience

• B.S. in Engineering, Science (Chemistry or Physics).  Master of Science in Engineering, Science is desired. 

• Minimum of5 years' experience supporting product development lifecycle (R&D, manufacturing, etc.) in medical or pharmaceutical industry with responsibilities for quality management.

• Strong understanding and implementation experience of design controls and product risk management including cybersecurity, 21CFR820, ISO13485, ISO 9001, ISO14971, IEC 62304, IEC 62443, IVDR and other applicable medical device regulations.

• Working knowledge in design control and process control, with emphasis of developing software and hardware medical devices.

Knowledge and Skills

oSound understanding of basic quality engineering sciences, including statistical process control (SPC) methods and application, quality planning, failure analysis investigation, risk management and process and software validation.

oHave a strong track record working with cross-functional product development teams.

oExpert in delivering business critical goals within a phase-gate based product development process.

oExpert in the development of risk management, applications of six sigma and daily management tools to drive cohesion and velocity.

o    Critical thinking and leadership skills; ability to develop strategies into clear actionable objectives and measurements.  Ability to understand implications and impacts across multiple functions.

oSkilled at facilitating team dynamics. 

oPossess the skills and ability to engage and influence other functions involved in the development of new products.

oDemonstrated ability to influence without authority and deal effectively with ambiguity.

oDrive for accountability within self and project team.

oDemonstrated project management skills.

oDemonstrated ability to make timely critical decisions.

oThe ability to prepare and understand technical documentation such as engineering drawings, operating procedures, work instructions, validations etc. 

oThe ability to communicate effectively in writing and orally, to organize work and to achieve results when working alone or in teams.

oStrong communication, problem solving, organizational and interpersonal skills.

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/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. 

Required Skills

Optional Skills

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Primary Work Location

USA CA - Milpitas 155

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

$130,400.00 - $215,200.00 USD Annual