GIE - EDE Staff Engineer

Becton Dickinson Medical Devices•Columbus, OH

About The Position

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. GIE EDE Staff Engineer Summary: This position is responsible for Assembly Design and Process Implementation across the Medical Segment business and is positioned to ensure that the company's component design, supply, cost, etc. are aligned to business expectations. This position provides expert engineering skill, judgement, and mentoring of other engineers. This role will oversee the planning, coordination and oversight in the development and implementation of assembly and packaging equipment and related activities as well as support new product development. This role will establish and maintain strong technical relationships at external vendors. Develops Strategies, Collaborates and Communicates with: Product Design Team: to ensure product is designed to enable a mfg. process which can produce product efficiently (target COGS) and to required quality standards. Unit Quality Team: to ensure that equip. is designed/manufactured in compliance with regulatory requirements/industry standards. Production Team: to ensure that equipment is designed for efficient production, and to support mfg. process. Maintenance/Engineering Team: to ensure max. equip. uptime, and that equip. is designed for easy maintenance/repair Procurement & Vendors: to ensure that components meet standards/safety and can be sourced timely/cost-effective. Plant Quality Team: to ensure that equip. is operating within specified tolerances and products meet required quality & regulatory standards. Production Team: to ensure that equipment is operating efficiently/effectively to meet production targets. Plant Maintenance Team: to ensure that equipment is maintained and serviced according to recommended schedules and procedures. Program Management Team: to ensure that project meets specified requirements that equipment is delivered on time within budget. 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. Scope: Medical segment operations manufacturing process technology across all manufacturing sites & all products. Build competitive advantage for the Medical segment business through the leverage of manufacturing process technology. Projects responsibilities and field of action are focus in developing equipment for Medical segment. This includes URS creation, equipment design, FAT execution and support SAT completion and approval, including vendor selection and PO. Managing one or several projects to perform and lead to success the above-described tasks.

Requirements

Minimum Education: Bachelor’s Degree in Mechanical Engineering, Electrical Engineering or related field
Minimum Experience: 5+ years in assembly equipment design / procurement is required
Excellent technical skills including project management, organization, planning, and capital budgets relating to equipment procurement and verification.
Demonstrated ability to apply problem solving and data analysis methods.
Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts desired.
Experience in an FDA regulated quality environment desired.
Willingness and ability to travel domestically and internationally up to 40%.
Experience leading projects end to end.
Strong communication skills
Risk analysis / FMEA
Statistical analysis / SPC system
Ability to manage multiple conflicting priorities, and to develop and maintain tool qualification schedules.
Physical requirement: Ability to use a laptop/computer for extended periods of time (up to 8 hours)
Ability to sit for long periods of time (up to 8 hours) in virtual and/or on-site meetings
Ability to stand for long periods of time (up to 8 hours) when conducting FAT, SAT, on-site equipment/process troubleshooting, etc.
Ability to climb steps, squat, etc.
Ability to work independently in High Volume manufacturing floor
Follow Safety and Quality/GMP requirements for medical device manufacturing site (Safety shoes, safety glasses, hair net, beard net, face mask, hard hat, etc….as required per manufacturing site)

Nice To Haves

Tooling design experience of assembly processes is desired
Proficiency in SolidWorks is desired

Responsibilities

Process Development (Quality, Efficiency and Harmonization): Responsible for the design of assembly and packaging equipment, responsible for user requirements specifications (URS) to ensure it meets specific manufacturing requirements.
Provide cost input (equipment, engineering, materials) into CB-2.
Manage the integration of new equipment through SAT completion, and support Equipment Integration during install and startup.
Implement Process Design on new equipment and ensure product designs are being met.
Provide feedback and validate that the equipment design meets safety and operational standards based on experience and validation from respective stakeholders.
Leads suppliers and external design teams (vendor) for larger capital projects to manage cost, lead time and scope.
Partnerships with procurement for vendor selection.
Active participant with suppliers regarding process optimizations and continuous improvements on automations projects
Captures process performance from sites, existing assembly lines
Responsible for vendor contracts in collaboration with procurement and legal.
Develop innovative concepts for mechanical systems and equipment based on project requirements, industry trends, and standard methodologies.
Create, or obtain from the vendor, detailed 3D models/2D drawings of mechanical components and assemblies using CAD software.
Create and maintain design documentation, including user requirement specifications, assembly instructions, bill of process, etc.
Optimize equipment designs to minimize production costs and changeover time, simplify assembly processes, design from the operator’s standpoint, maintainability, and ensure manufacturability.
Participate in design reviews, risk assessments, and continue to build failure mode and effects analysis (FMEA) to ensure reliability, safety, performance of mechanical systems/equipment.
Collaborates with manufacturing teams to build and test prototypes of mechanical systems and components, gathering feedback, iterating on design as necessary.
Perform various engineering analyses / simulation (i.e. stress, strain, thermal, fluid dynamics) to validate and optimize design.
Work closely with other engineering fields. (i.e. electrical/mechanical engineers) to ensure seamless integration of mechanical systems with other project components.
Support operations during a production crisis. (quality, supplier, etc.)
Comply with all local, state, federal, and BD safety regulations, policies, and procedures.
Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
Other duties as assigned.