Job Description Summary

Responsible for quality of assigned BD Biosciences (BDB) New Product Development (NPD) medical devices products to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products cover In Vitro Diagnostic (IVD) assay products comprised of the instruments, reagent and systems used for the collection, preparation and examination of biological samples to diagnose diseases or other conditions. These products are produced by BDB plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships. Develops the appropriate Regulatory, Quality and Product Development strategies for NPI products in concert with Regulatory Affairs, Marketing, Product Development and other cross-functional stakeholders.

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

Project Leadership:

• Lead extended quality teams in the planning and execution of new product introduction projects from feasibility through to commercialization.

• Develop and manage project timelines, budgets, and resources to ensure timely and successful product launches.

• Serves as the primary quality lead for project activities and the team members (within and outside of BDB) to achieve on-time quality work, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization.

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.

Assay Product/Production Integration:

• Oversee the integration of IVD assay production by collaborating closely with BU Platforms, manufacturing, and contract manufacturers to ensure alignment with quality standards for overall assays.

Statistical Analysis:

• Apply statistical analysis techniques to support quality decision-making, including design of experiments (DOE), control charting, and statistical process control (SPC).

Cross-Functional Collaboration:

• Work effectively with multi-functional teams, including R&D, regulatory affairs, and post-market teams, to ensure well-rounded quality management and compliance across all subject areas.

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.

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.

• Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation

• Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.

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.

Lean Principles:

• Apply lean manufacturing principles to improve processes, minimize waste, and enhance efficiency in assay production and development.

3rd Party Assessment

• Perform 3rd party supplier and/or contractor manufacturer management activities such as review and approval of 3rd party design control activities, assess 3rd party changes and ensure of appropriate balance between internal oversight actions and supplier controls, provide guidance to quality agreements, perform relationship development, and visit supplier sites.  Support supplier audits as required.  Partner with Third Party Vendors/Manufacturers/Laboratories to ensure that products/devices are in compliance with internal and Regulatory Agency standards

• Establishes and maintains relationships and open communication with suppliers, contract manufacturers, BDB plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.

Continuous Improvement:

• Drive continuous improvement initiatives in the NPI process, using lessons learned and industry best standard methodologiesnhance product quality and efficiency.

• Mentor and train junior engineers and team members on NPI processes, software validation, and cybersecurity risk management.

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Stakeholder Communication:

• Serve as the primary point of contact for stakeholders regarding NPI projects, providing regular updates on progress, challenges, and achievements.

• 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 of 15 years' experience in quality engineering or similar engineering discipline.

• Minimum of 8 years' experience supporting product development lifecycle (R&D, manufacturing, etc.), where 5 of those years are progressive experience in software/electromechanical instrument in Medical Device/IVD industry with responsibilities for quality management.

• Strong understanding of regulatory requirements and guidelines applicable to IVD products.
  - Proficient in risk management methodologies, statistical analysis, and lean principles.
  - Experience with the integration of IVD assay production, including reagents and instrument assays.
  - Excellent analytical skills, with the ability to interpret complex data and metrics effectively.
  - Strong communication and interpersonal skills, with a proven ability to work collaboratively across disciplines.

Preference:

• CQE and/or CMQ/OE

• Six-Sigma certification is preferred.

• Knowledge in flow cytometry and genomic technologies to inform product development strategies and quality evaluations.

Knowledge and Skills:

• 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.

• Sound 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.

• Practical knowledge in design control and process control in a regulated industry.  With emphasis of developing software and hardware medical devices.

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

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

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

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

• Skilled at facilitating team dynamics. 

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

• Demonstrated ability to influence without authority and deal effectively with ambiguity.

• Drive for accountability within self and project team.

• Demonstrated project management skills.

• Demonstrated ability to make timely critical decisions.

• The ability to prepare and understand user documentation such as engineering drawings, operating procedures, work instructions, validations etc. 

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

• Strong 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 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 - Milpitas 155

Additional Locations

USA CA - San Diego (BDB)

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