BD (Becton, Dickinson and Company) Senior Manufacturing Engineer in Franklin Lakes, New Jersey
Job Description Summary
At BD Medical – Diabetes Care, a business unit of Becton Dickinson & Co., we are currently strengthening our core capabilities for new manufacturing technology & process development in the field of diabetes management devices. The business unit is comprised of approximately 2,300 associates globally, with headquarters in Franklin Lakes, NJ. We are looking for highly innovative, passionate, and talented individuals to join our Operations team, where you will have the opportunity to play an important role in the development of BD’s next generation manufacturing technology. If you are interested in participating in the creation of exciting and revolutionary products that will improve the lives of millions of people living with diabetes, read on...
The Senior Manufacturing Engineer will support the team through design, development, and commercialization of new Diabetes Care products and processes. This talented and passionate individual will be responsible for delivering innovative and practical manufacturing solutions that support various product development road maps.
Duties & Responsibilities
Working at the direction of the group leader, oversee internal and external resources, in the development of manual / semi-automated / fully-automated processes for product assembly and packaging.
Identify and select methods and fixtures to evaluate and screen, through proof-of-principle efforts, potential production processes.
Responsible for design, characterization, acceptance, and validation of prototype equipment and pilot processes in support of manufacturing scale-up.
Drive Design forManufacturing/Assembly(DFM/A) activities and process specification definition throughout product development lifecycle.
Manage external OEM vendors to stringent timelines and capability requirements through URS, RFQ, design reviews, process characterization and equipment acceptance (FAT & SAT).
Support design control efforts in creation of specifications and test method development.
Support 3D modeling and tolerance analysis of complex electromechanical systems.
Support/perform design reviews, FMEA’s, risk / hazard analysis & establishing technical requirements.
Support identification and qualification of suppliers for specialty materials and equipment.
Author specification and acceptance protocols for process equipment and validation as required. Oversee vendor efforts through facilitation of reviews, cadenced meetings, and program tracking.
Apply lean manufacturing methodologies to characterize, debug, and optimize manufacturing processes.
Support supply chain development and prototype part sourcing oversight efforts as assigned.
Support delivery of process engineering deliverables as assigned.
Desired Knowledge & Skills:
Working knowledge of methods and procedures used in the manufacture and quality control of Class 2 devices (Class 3 medical diagnostic products preferred).
Hands-on experience with fixture design as well as development and troubleshooting of machines and process operations for high-speed complex automation, including packaging.
Excellent understanding of medical device product development risk management methodologies.
Knowledge and experience with SolidWorks.
Demonstrated proficiency with data analysis and statistical techniques using Minitab (or equivalent statistical software).
Working knowledge of Design of Experiments (DOE), Design forManufacturing/Assembly(DFM/A), Measurement System Analysis (MSA), Gage R&R, and Design Control.
Clear understanding of product and process validation including V&V, TMV, FAI, FAT/SAT, IQ/OQ/PQ, etc.
Experience writing equipment specifications.
Six Sigma proficiency (greenbelt preferred) and understanding of Lean and Continuous Improvement (CI).
Must be highly motivated with good organizational and analytical/technical problem solving skills.
Effective written and oral communication skills; capable in communicating to multiple audiences, and senior management personnel.
Effective organization, project management and planning skills.
Very strong and effective interpersonal skills.
Ability to manage competing simultaneous priorities effectively.
Education & Experience:
B.S. degree in Mechanical, Biomedical, or related Engineering discipline is required.
The candidate is expected to have a minimum of 2-5 years relevant experience, and knowledge in the fields of process development, manufacturing, and project engineering.
Manufacturing plant experience with process and equipment related background is preferred.
Experience developing fixtures, equipment, and processes for manufacturing.
Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes.
- Up to 30-40% domestic or international travel
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.
Primary Work LocationUSA NJ - Franklin Lakes
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