Senior Manufacturing Engineer

Job Description Summary

This position is responsible for Assembly & Packaging Equipment Design and Process Implementation across the Life Sciences Business Segment comprised of the BDB, SM, DS businesses and is positioned to ensure that the company's equipment design, supply, cost, etc. are aligned to business expectations. This position provides expert engineering skill, judgement, and mentoring to engineers and team members. This role will oversee the specification, quoting, sourcing and build of equipment refurbishments as well as new equipment and lines to support the business needs.

Job Description

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. 

Responsibilities

Process & Equipment Development (Quality, Efficiency and Harmonization):

• Responsible for the generation of the user requirements specifications (URS) design (mechanical and/or electrical) and build of assembly and packaging equipment. Responsible for the commissioning (FAT through SAT) of automated and packaging equipment.

• Create capital appropriation documents 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 stake holders.

• 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 molding projects

• Captures process performance from sites, existing molds.

• 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.)​

• Follow all local, state, federal, and BD safety laws, and procedures.

• Align with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.

• Other duties as assigned.

Education and Experience:

• Education:

  • Bachelor’s degree in Mechanical or Electrical Engineering or a related field preferred or equivalent experience (10 years)

  • Equivalent hands-on experience and years of service may be considered on a case-by-case basis.

• Experience:

  • Minimum of 5 years of engineering experience.

  • Preferred background in packaging and automated manufacturing equipment with process development in high-volume manufacturing.

  • Experience with medical devices, in-vitro diagnostic, and pharmaceutical products is a plus.

  • Experience implementing process improvements and launching new equipment into a manufacturing environment.

  • Comprehensive understanding of all project phases: brainstorming, scoping, budgeting, writing specifications, quoting, capital proposals, vendor management, coordinating installations, and running validations.

  • Experience with label printing and barcode specifications and requirements, as well as packaging cost analysis.

  • Experience leading projects end-to-end.

  • Experience in an FDA-regulated quality environment is desired.

  • Previous experience with Good Manufacturing Practice (GMP), ISO standards, and Lean Manufacturing concepts is desired.

  • Willingness and ability to travel domestically and internationally up to 25% annually.

Knowledge, Skills, and Abilities:

• Technical Skills:

  • Proficiency in AutoCAD and/or SolidWorks is desired.

  • Excellent technical skills including project management, organization, planning, and capital budgets relating to mold procurement and verification.

  • Demonstrated ability to apply problem-solving and data analysis methods.

  • Proficient in CAD, WORD, Excel, MS Project. Working knowledge of Minitab is a plus.

  • Risk analysis / FMEA.

  • Statistical analysis / SPC system.

• Communication Skills:

  • Strong communication skills.

  • Ability to manage multiple conflicting priorities and to develop and maintain tool qualification schedules.

• Physical Requirements:

  • Ability to use a laptop/computer for extended periods (up to 8 hours).

  • Ability to sit for long periods (up to 8 hours) in virtual and/or on-site meetings.

  • Ability to stand for long periods (up to 8 hours) when conducting FAT, SAT, on-site equipment/process trouble shooting, etc.

  • Ability to climb steps, squat, etc.

  • Ability to work independently on a high-volume manufacturing floor.

  • Follow Safety and Quality/GMP requirements for a medical device manufacturing site (e.g., safety shoes, safety glasses, hair net, beard net, face mask, hard hat, etc., as required per manufacturing site).

Work Environment:

• BD is a smoke-free campus.  Smoking and the use of electronic smoking devices, marijuana, or tobacco products are not allowed on BD property, grounds or in the parking areas.  We appreciate your cooperation in adhering to this policy

• False eyelashes, press-on fingernails, and Jewelry is not allowed on the production floor including dermals.  Any associate wearing dermals will be required to cover them while working on the production floor. 

• Shoes are required to be Steel Toe and non-slip for all associates while on the production floor for safety purposes.

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.

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.  

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. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers 

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. 

Required Skills

Optional Skills

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Primary Work Location

USA SC - Sumter

Additional Locations

Work Shift