GIE EDI Sr. Staff Engineer for Specimen Management

Becton Dickinson Medical Devices•Sumter, SC

31d•Onsite

About The Position

The Senior Staff Engineer for Equipment Development & Industrialization (EDI) leads the development and deployment of manufacturing equipment and process technologies for the Specimen Management Business Unit. This role translates new product development (NPD) and design change requirements into robust equipment and operator-centric processes that enable efficient, compliant, and cost-effective production. This position partners with Product Design, Quality, Operations, Procurement, and external suppliers to ensure timely delivery of equipment and smooth vertical ramp-up across assigned sites. This position manages a portfolio of projects , participates in capital planning , and ensures adherence to stage-gate governance . Success is measured by o n-time project delivery, OEE improvement, COGS reduction, and compliance with regulatory standards .

Requirements

B.S. in Engineering (Mechanical Engineering preferred).
10+ years in equipment/process development and leadership.
Proven ability to manage capital projects , influence cross-functional teams, and deliver results in regulated environments.
Experience with stage-gate governance , risk analysis (FMEA) , and validation .
Strong financial acumen and project management skills.
Familiarity with Lean , SPC , and continuous improvement methodologies .

Nice To Haves

MBA or MS in Engineering is preferred.
Bachelor’s in Mechanical, Electrical, or related Engineering; advanced degree preferred.

Responsibilities

Develop and execute the equipment and process technology roadmap for assigned sites/products aligned with segment priorities.
Define URS and equipment specifications to meet manufacturing, safety, and regulatory requirements.
Partner with PMO to ensure budget, timeline, and scope compliance for all EDI projects.
Lead multiple capital projects from concept through FAT/SAT, installation, and validation.
Manage vendor relationships , including selection, contracting, and performance oversight.
Ensure risk management through FMEA, design reviews, and validation protocols.
Work with Product Design to embed Design for Manufacturability (DFM) principles early in development.
Align with Quality/Regulatory to ensure compliance with GMP, ISO, and FDA requirements .
Collaborate with Operations & Maintenance to design equipment for reliability, maintainability, and operator safety .
Oversee equipment integration and process optimization during ramp-up.
Drive standardization and best-practice sharing across assigned sites.
Support structured problem-solving during production issues and implement systemic improvements.