Job Description Summary

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. 

Position Summary

The Senior Manager of EMI (Electromechanical Instruementation) Quality Sustaining Engineering reports to the Global Director of EMI Quality. This role is responsible for planning and execution of Sustaining Engineering activities to keep products in compliance with applicable standards and improve customer experience. This role also assists in developing and maintaining quality assurance programs, policies, procedures, and controls for pre-production supplier qualification, capability development, and manufacturing quality. It ensures product performance and quality meet requirements, standards, and regulations for all BU EMI product platforms.

Sustaining Quality engineers at the EMI plant locations will report directly to the Senior Manager and are under their authority for performance reviews, career development, compensation, hiring, and termination. The Senior Manager also partners with operational or platform team leaders, operating with independence but under oversight from senior quality and regulatory compliance leaders.

Key Responsibilities

• This leader will provide input into and support the Director of EMI Quality development of the overall EMI sustaining quality strategy.

• This leader will work with the respective BU platform teams when a design change is needed in support of sustaining projects.

• This leader will drive the customer facing lens of quality with a focus on instrument performance at install and while in the field.

• They will drive teams to deliver on improvements to drive improvement instrument reliability.

• This leader will develop quality programs to oversee and foster: process capability, new products supplied component readiness and introduction, product enhancements, material changes, operations quality and supplier quality expert-level leadership and guidance for a dedicated team.

• Define and influence a quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and developing them.

• Actively identify improvements to the processes within the QMS to enhance both compliance and quality.

• Provide expert-level understanding of qualification and validation, nonconformance control, process capability, risk reduction, and supplier management requirements and how to deploy them in a large-scale and rapidly evolving business.

• Provide operations and quality leadership during FDA and notified body site inspections.

• Interface with the FDA on Post-Market Activities: site inspections, manufacturing complaints, additional information requests.

• Acquire and develop excellent-level leaders and teams to support the EMI mission and actively manage bench-strength and succession planning.

• Assess resource needs to align the required level of quality support provided when needed with suitable competencies, including shifting resources between Platforms when appropriate.

• Maintain effective design-related quality metrics and define and execute activities to improve performance.

• Actively support and demonstrate the BD values in daily work.

• Other assignments as directed by the Director of EMI Quality.

Education

• Bachelor’s degree in a technical field required. Engineering degree strongly preferred. 

• Master’s degree in a technical field preferred.

Experience

• Minimum of ten (10) years’ experience in Quality Assurance and Risk Management

• Minimum of three (3) years’ experience with electromechanical instrumentation devices

• Working knowledge of (ISO 14971), and ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements, Quality Assurance/Control, Statistical analysis, and FDA QSR’s (21 CFR Part 820)

Required Knowledge and Skills

• Experienced in project management.

• Organizational / motivational skills.

• Capable of managing a range of projects and activities in parallel.

• The ability to manage by influence in addition to functional responsibility.

• The preparation, planning and presentation of key initiatives.

• The ability to coordinate effectively across regions.

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.

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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.

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