Sobre este puesto de EDI Staff Engineer en BD
We are the people who give possibilities purpose
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.
Job Description
Responsibilities
Develops Strategies, Collaborates and Communicates with:
Product Design Team: Support manufacturable product designs aligned with cost and quality targets.
Unit and Plant Quality Teams: Support compliance with regulatory, GMP, ISO, and validation requirements.
Production Teams: Ensure equipment is operable, reliable, and capable of meeting production targets.
Maintenance / Engineering Teams: Support uptime, maintainability, and troubleshooting readiness.
Procurement & Vendors: Support sourcing, supplier technical alignment, and execution milestones.
Plant Quality Team: to ensure that equip. is operating within specified tolerances and products meet required quality & regulatory standards.
Program Management: Support delivery of equipment and automation scope on time and within budget.
Finance Team: Support CapEx tracking and reporting.
RESPONSIBILITIES
1. Process & Equipment Design and Development
Support design and development of assembly, packaging, automation, inspection, and manufacturing equipment including mechanical, electrical, and control elements.
Support preparation, maintenance, and execution of User Requirement Specifications (URS).
Support evaluation of technical concepts considering risk, scalability, validation impact, cost, and lifecycle requirements.
Participate in design reviews, machine safety reviews, risk assessments, and FMEA activities.
Lead Proof of Concept (POC) evaluations and Design of Experiments (DOE).
Verify relationships between Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs).
Develop center lining activities to optimize equipment performance.
Identify opportunities to improve equipment operability, ergonomics, maintainability, reliability, and cost of ownership.
Lead and support problem solving activities related to Equipment & Automated Systems.
Troubleshoot equipment systems, materials, or process issues using scientific approaches.
Lead and Support POC evaluation and DOE to establish baseline processes and metrics.
2. Supplier & Capital Project Support
Support coordination with equipment suppliers and system integrators.
Support RFQs, technical evaluations, and supplier capability reviews.
Review supplier designs, specifications, and safety concepts under guidance.
Participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
Support deviation tracking, corrective actions, and issue resolution.
3. Equipment Integration, Installation, Validation & Start-Up
Support execution of equipment installation plans and site readiness activities.
Execute and support qualification, process verification, and process validation activities.
Support vertical start-up and production ramp-up activities.
Minimize disruption to ongoing operations during equipment or automation integration.
Troubleshoot equipment and automation issues using structured problem-solving tools.
Execute process verification and production ramp-up activities for Equipment & Automated Systems.
4. Ramp-Up, Performance & Continuous Improvement
Provide technical support during ramp-up to achieve OEE, yield, throughput, and reliability targets.
Measure and analyze gaps between expected and actual performance.
Lead continuous improvement and Lean Manufacturing initiatives.
5. Documentation, Training & Handover
Support creation and handover of equipment documentation including specifications, drawings, FAT/SAT, validation, maintenance and control plans.
Support preparation of operating instructions and troubleshooting documentation.
Support training of site personnel on new equipment and processes.
Support formal handover to Operations, Maintenance, Engineering, and Quality teams.
6. Compliance, Safety & Quality
Ensure compliance with EHS, machine safety, ISO, FDA, GMP, and BD Quality System requirements.
Support internal and external audits, inspections, and regulatory interactions.
Equipment Engineering Scope
Execute process verification, process validation, and production ramp-up activities for Equipment & Automated Systems.
7. Performance Indicators (Accountability)
Leading KPI
Number of Equipment design, Cost of production & OEE. Percentage of project completed on time, in scope and to budget.
Integration lead time reduction and milestone adherence.
Completion of validation and readiness activities.
Lagging KPI
Equipment Reliability Overall Equipment Effectiveness Number of process failures experienced.
Lagging KPI
Equipment OEE and reliability during ramp-up.
Equipment-related quality or safety incidents.
EXPERIENCE/EDUCATION
Minimum Education:
Bachelor’s Degree in Mechanical Engineering, Controls Engineering or related field, or relevant equivalent experience.
Minimum Experience:
3 years of progressively responsible engineering and project management experience.
Extensive experience in integrating equipment within complex manufacturing sites with a strong focus on validation and vertical start up.
Experience in SolidWorks or other 3d modeling software is desired
Excellent technical skills including project management, organization, planning, and capital budgets.
Demonstrated ability to apply problem solving and data analysis methods.
Proven lean leadership experience who can assimilate data in a structured manner and present recommendations based on facts and data.
Proven leadership in project and capital management.
Exceptional communication and presentation skills.
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)
MAIN CONTACTS TO DO THE JOB:
Internal Reasons
GIE other Teams
Manufacturing teams
BU functions: Quality, SC.
External Reasons
Vendors, Customers, Consultants, procurement, Quality
WW R&D project teams
Machine vendors
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
BD is committed to providing a robust set of value-based programs and resources that are best-in-class, market-competitive and affordable for all associates and their families.
Competitive pay
Access a portion of your pay before pay day with DailyPay
Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover.
Preventive care covered at 100%.
Dental and vision insurance at group rates.
Paid parental leave up to 6 weeks
Adoption assistance plan
401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation
Company paid basic life and AD&D insurance
Tuition reimbursement
Discounted home, auto and pet insurance
Paid holidays and vacation (pro-rated the first year based on actual start date)
All benefits and policies are subject to eligibility and enrollment requirements. Most coverage begins on your first day or the date you become eligible for benefits.
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, 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, and other legally protected characteristics.
Required Skills
Optional Skills
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