Director, Reagent MFG Sustaining Engineering

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.

Descriptions Director, MFG Sustaining Engineering

Leading multi-functional Sustaining Core team(s) and Project team(s) within a matrix and, FDA and ISO compliant organization, responsible for managing multiple sustaining manufacturing engineering projects which heavily interfaces with site manufacturing, scientific/technical, quality and R&D teams role will manage a high volume of projects by implementing a structured sustaining process and ensures timely completion.

The Director, MFG Reagent Sustaining Engineering is accountable for leveraging new and diverse approaches resulting in optimized solutions by leading the team through technical, quality, regulatory, manufacturing, and commercial problem solving and decision making, ensuring that the functional experts are held accountable.

Job Responsibilities:

• Supply Chain Assurance
  
  • Provide support for new or replacement supplier selection, qualification and resolution of quality issues, including the definition of incorporation of critical feature inspection and test points in the manufacturing and QC process.
  • Accountable for engineering support and technology aspects of BDB reagent manufacturing processes required to meet long-term manufacturing output, efficiency, quality, and cost objectives.
  • Provide industry standard expertise for process automation and engineering to help improve process capacity, cost and unit volumes.
  • Works with BDB Reagent Plant Managers world-wide to provide engineering support and systems to meet long-term production goals.
  • Works with corporate level functions driving cross business efforts in BDB reagent Manufacturing for best practices with NPI, and the implementation of cost-reduction, re-design and PPV efforts
  • Maintains connections with industry and professional organizations. Stays informed of and sources new technology as required to meet manufacturing objectives.
  • Leverages process and system uniformity across multiple manufacturing sites
  • Responsible for development and implementation of a manufacturing engineering strategy and programs to the support BDB manufacturing plants and operations

• Sustaining Engineering
  
  • Participate on the Executive Sustaining Governance Committee meetings, providing strategic guidance and recommendations as it pertains to decisions on Sustaining Engineering Process and Programs or Projects
  • Employ disciplined value engineering processes to gather information, identify alternatives, analyze the cost/benefit, and select the best opportunities to execute
  • Ensures that the portfolio of Sustaining Engineering Projects is prioritized and executed in accordance with overall business objectives
  • Accountable for driving CI/PPV/Re-design elements while working collaboratively with plant leadership, supply chain, quality, regulatory, R&D and business/platform leadership

• Support and Product Lifecycle Governance
  
  • Accountable to establish a Product Lifecycle Engineering governance body and process to effectively manage the portfolio for cost effective product end of life.
  • Actively participates in new project proposal review, valuation, classification and platform prioritization.
  • Partners with NPI team and Production Manager Teams to be efficiently implement new products and acquisitions into manufacturing internally or to transfer to a CM in a global manufacturing environment.
  • Works closely with R&D developing effective technology transfer processes and plans for new and existing reagent platforms. Implements manufacturing systems for effective new product transfer per key business objectives.

• Engineering Leadership
  
  • Identify and resolve gaps in key competencies, leadership, skillsets and succession depth to meet business need
  • Lead manufacturing sustaining engineering to provide technical product line support to ensure quality, delivery, and cost goals. Identify and drive implementation of continuous improvement projects such as, first pass yield, cycle time reduction, product reliability, customer complaints and cost reduction.
  • Develops and maintains capital and financial budgets for assigned departments.
  • Responsible for establishing overall strategy and execution performance levels for Operations sustaining engineering leadership and technical team.
  • Assess project resource skill, loading, and time allocation requirements and assure the appropriate allocation of a broad engineering resource skill base across multiple plants.

• Quality / Compliance
  
  • Responsible for developing and maintaining compliance with the Quality system, provide technical support for Material Review Board (MRB) and CAPA review.
  • Develop technical depth for problem resolution, manufacturing processes, lean manufacturing, and business processes (ECOs, MRB, CAPA and ERP applications)
  • Ensure safety program meets EH&S requirements.
  • Familiar with GMP's, ISO requirements, the IVD Directive, CE marking, Six Sigma and LEAN principles.

Minimum Qualifications:

• Minimum twelve (12) years' experience in product Manufacturing Sustaining Engineering in a regulated (ISO/IVD) regulated operation

Education and Experience:

• Bachelor's Degree is required in Engineering and post graduate degree (e.g. MBA or Masters or PhD) is preferred
• Black Belt or Design For Six Sigma and PMP are also preferred
• Track record of success in leading and managing complex, reagent engineering projects
• Experience in life sciences, biotechnology medical device or diagnostic industries
• Experience in managing projects to meet changing regulatory requirements is preferred
• Experience working in Design Control, Change Management, ISO and FDA environment
• Understanding of regulations, standards and guidelines related to IVD, and/or medical devices and quality systems including 21 CFR, IVDD, IVDR, ISO14971, ISO13485, etc.
• Experience managing external suppliers, vendors and contractors
• Effective verbal, written and presentation skills required.
• Ability to travel up to 50%

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.

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.

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. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.

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 ;/b>

Required Skills

Optional Skills

Primary Work Location
USA CA - San Diego (BDB)

Additional Locations
USA CA - Milpitas 155, USA PR Cayey - Vicks Drive (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

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