Director, Reagent MFG Technical Engineering

Description

s Director, Reagent MFG Technical Engineering

Leading multi-functional technical engineering Core team(s) and Project team(s) within a matrix and, FDA and ISO compliant organization, responsible for managing multiple technical manufacturing engineering projects which heavily interfaces with site manufacturing, scienctiifc / technical, quality and R&D teams. The role will manage a high volume of projects by working closely with all team corporate and site resources to execute projects based on need and timeline.

The Director, Reagent MFG Technical 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 :

Manufacturing and Supply Chain Assurance

Provide end ot end support for 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 manufacturing output, efficiency, quality, and cost objectives

Works with BDB Reagent Plant Managers world-wide to provide engineering support and systems to meet production goals

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 reagent 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

Helps ensure that the portfolio of Sustaining Engineering Projects is prioritized and executed in accordance with overall business objectives

Support and Product Lifecycle Governance

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

Engineering Leadership

Identify and resolve gaps in key competencies, leadership, skillsets and succession depth to meet business need

Lead technical engineering to provide technical product line support to ensure quality, delivery, and cost goals. Identify and help drive implementation of continuous improvement projects such as, first pass yield, cycle time reduction, product reliability, customer complaints and cost reduction.

Helps develop and maintains capital and financial budgets for assigned departments

Responsible for establishing overall strategy and execution performance levels for Operations technical engineering leadership.

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 Technical 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

Proven track record of success in leading and managing 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.