We are the people who give possibilities purposeBD 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.
Job Description
Responsibilities
- Product Design / R&D Teams: Ensure products are designed to enable efficient, scalable, and compliant manufacturing processes meeting cost, quality, and regulatory objectives.
- Manufacturing & Operations Teams: Ensure integrated equipment and processes are operable, reliable, maintainable, and capable of meeting production targets from handover through steady-state operations.
- Quality & Regulatory Teams: Ensure compliance with validation strategies, GMP, ISO, FDA, and internal quality system requirements.
- Maintenance & Engineering Teams: Ensure long‑term equipment reliability, centre lining strategies, spare parts management, and maintenance readiness.
- Program & Project Management: Ensure alignment on scope, cost, schedule, risk, and delivery milestones.
- Procurement, Suppliers, and Vendors: Drive supplier technical alignment, capability development, and delivery performance.
- Finance: Support CapEx planning, forecasting, and reporting.
- EHS Teams: Ensure machine safety, ergonomics, environmental compliance, and risk mitigation.
Process & Equipment Strategy, Design and Development
- Provide technical ownership and strategic direction for assembly, packaging, automation, inspection, moulding, press, and manufacturing equipment.
- Translate business, product, quality and capacity requirements into robust end‑to‑end equipment and automation strategies.
- Define, create, review, and approve User Requirement Specifications (URS) ensuring clear translation to supplier designs and site needs.
- Lead the development and evaluation of multiple technical concepts, architectures and solutions considering risk, scalability, standardisation, lifecycle cost and validation impact.
- Develop innovative mechanical and automation concepts aligned with BD standards, industry best practices and emerging technologies.
- Review and approve mechanical, electrical and controls architectures, layouts, 3D models, 2D drawings and system interfaces.
- Provide expert oversight of engineering analyses and simulations (stress, strain, thermal, airflow, cycle time) to validate and optimise designs.
- Lead and approve design reviews, machine safety reviews, risk assessments and FMEA activities.
- Support and lead Proof of Concept (POC) activities and Design of Experiments (DOE) to define process windows and establish baseline performance.
- Verify and approve relationships between KPIVs and KPOVs and ensure process capability is demonstrated.
- Optimise equipment and process designs to improve performance, reliability, ergonomics, changeover time, maintainability, manufacturability and total cost of ownership.
- Provide authoritative technical and cost input to capital justification (CB-2) including risk, validation effort and sustainability of performance.
Supplier, Vendor & Capital Programme Leadership
- Act as technical lead for supplier and system integrator engagement on large or complex capital programmes.
- Lead and approve vendor selection, RFQs and technical evaluations in partnership with Procurement.
- Define and control supplier technical scope, interfaces, cost, lead time, risks and performance expectations.
- Review and approve supplier designs, specifications, safety concepts, automation architecture and documentation.
- Lead, witness and approve Factory Acceptance Tests (FAT) including acceptance criteria, deviation management and corrective actions.
- Oversee supplier issue resolution, design changes and continuous improvement actions.
- Support contract execution, change management and claims resolution with Procurement and Legal.
- Establish and maintain strong long‑term technical relationships with strategic equipment suppliers.
Equipment Integration, Validation & Start‑Up
- Provide technical leadership for end‑to‑end equipment integration into operating manufacturing environments.
- Approve and oversee installation, integration and commissioning strategies including site readiness, utilities, layout, logistics and EHS compliance.
- Lead and approve SAT, commissioning, qualification and validation strategies.
- Ensure execution of equipment qualification, process verification and process validation in compliance with regulatory and quality requirements.
- Approve validation protocols, reports and acceptance decisions.
- Lead and support vertical start‑up ensuring equipment, process, documentation, materials and personnel readiness.
- Act as escalation point for complex integration, automation and performance issues.
Ramp‑Up, Performance & Continuous Improvement
- Ensure achievement and sustainability of OEE, yield, throughput, scrap, reliability and capacity targets during ramp‑up and early production.
- Lead and approve centre lining strategies to stabilise and optimise long‑term equipment performance.
- Oversee performance gap analysis between expected and actual results and drive corrective action plans.
- Champion Continuous Improvement (CI) initiatives leveraging Lean Manufacturing, data analytics and standardisation.
- Drive lessons learned, best practices and technology reuse across sites and programmes.
Documentation, Training & Handover
- Ensure completeness and quality of all equipment and validation documentation, including URS, specifications, drawings, FAT/SAT reports, qualification/validation records, maintenance and control plans, spare parts lists and software backups.
- Approve operating instructions, troubleshooting guides, standard work and maintenance procedures.
- Ensure site training and capability transfer is completed prior to handover.
- Approve formal handover to Operations, Maintenance, Engineering and Quality functions.
Compliance, Safety & Quality Leadership
- Ensure full compliance with EHS, machine safety, ISO, FDA, GMP and BD Quality System requirements.
- Act as technical authority during audits, inspections and regulatory interactions related to equipment and processes.
- Promote and model a strong safety, quality and compliance culture across all projects.
Technical Leadership & Mentoring
- Serve as a senior technical authority and subject matter expert within GIE EDI.
- Mentor and develop engineers across levels, providing technical guidance and coaching.
- Lead complex technical discussions and decision‑making across global, cross‑functional teams.
- Drive global standardisation, harmonisation and knowledge sharing initiatives.
Required Qualifications
- Bachelor's Degree in Engineering (Mechanical, Electrical, Controls, Automation, Manufacturing or related field), or equivalent experience.
- 8 years of progressively responsible experience in equipment design, automation, manufacturing engineering and capital project delivery.
- Extensive experience integrating equipment in complex, regulated manufacturing environments with strong focus on validation and vertical start‑up.
- Proven leadership in large or complex capital projects.
- Demonstrated expertise in Lean Manufacturing, DOE, SPC, FMEA and structured problem solving.
- Willingness and ability to travel internationally as required by project needs.
Preferred Qualifications
- Experience in an FDA regulated quality environment desired.
Knowledge and Skills
- Strong ability to synthesize data, risks and technical information into clear recommendations.
- Recognised technical authority in manufacturing equipment and automation systems.
- Strong capital programme and stakeholder management capabilities.
- Exceptional analytical, problem‑solving, communication and presentation skills.
- Ability to influence without authority across global organisations.
Required Skills
- At BD, we prioritise on‑site collaboration because we believe it fosters creativity, innovation and effective problem‑solving, which are essential in the fast‑paced healthcare industry.
Optional Skills
Primary Work Location
Additional Locations
Work Shift
Why Join Us?
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 healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress and your success. 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, colour, 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 SkillsOptional Skills.Primary Work LocationUSA UT - SandyAdditional LocationsWork Shift