BD (Becton, Dickinson and Company) Staff Manufacturing Engineer in Franklin Lakes, New Jersey
Job Description SummaryAt BD Medical – Diabetes Care, a business unit of Becton Dickinson & Co., we are currently strengthening our core capabilities for 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.
The Staff Manufacutring Engineer is responsible for leading the development and implementation of manufacturing process technlogies for the Diabetes Care family of products. We are looking for highly innovative, passionate, and talented individuals to join our Operations team. If you are interested in participating in a high volume, fast paced business that will improve the lives of millions of people living with diabetes, read on...
The Staff Manufacturing Engineer will support the operations team in developing and executing manufacturing strategies for existing and new Diabetes Care products. This talented and passionate individual will be responsible for delivering innovative and practical manufacturing solutions that support various product development road maps. In addition to technical expertise, the Staff Manufacturing Engineer will bring strong leadership and team building skills fostering an environment of growth and personal development.
Duties & Responsibilities:
Working at the direction of the Engineering Leader, oversee internal and external resources, in the development of manual / semi-automated / fully-automated processes for product assembly. Ranging from low to high volume implementations.
Works with globally located and cross functional teams at business unit and plant level to achieve project goals.
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 for Manufacturing/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.
Demonstrates the ability to effectively manage technical projects. From stakeholder management, cross-functional leadership, risk identification to successful project closure.
Support supply chain development and prototype part sourcing oversight efforts as assigned.
Support delivery of process engineering deliverables as assigned.
Desired Knowledge & Skills:
Must be highly motivated with good organizational and analytical/technical problem solving skills.
Must be a self-starter with capability of working under minimal supervision.
Very strong and effective interpersonal skills with the ability to lead and develop others.
Effective written and oral communication skills; capable in communicating to multiple audiences, and senior management personnel.
Effective organization, project management and planning skills.
Ability to manage competing simultaneous priorities effectively.
Working knowledge of methods and procedures used in the manufacture and quality control of medical devices.
Demonstrated understanding of process development considerations for tightly controlled, high-volume manufacturing designs & processes.
Hands-on experience in the troubleshooting of machines and process operations for high-speed complex automation, including packaging.
Excellent understanding of medical device product development risk management methodologies.
Clear understanding and hands-on experience of product and process validation including V&V, TMV, FAI, FAT/SAT, IQ/OQ/PQ, etc.
Experience writing equipment specifications, operating procedures, and managing design efforts of equipment vendors.
Working knowledge of Design of Experiments (DOE), Design for Manufacturing/Assembly (DFM/A), Measurement System Analysis (MSA), Gage R&R, and Design Control.
Six Sigma proficiency (Black Belt or DFSS preferred)
Lean and Continuious Improvement (CI) profeciency with expereience in waste reduction.
Experience managing capital budgets and project timelines across multifunctional disciplines.
Demonstrated proficiency with data analysis and statistical techniques using Minitab.
Experienced SolidWorks, MS Office / Project / Visio user.
SAP experience preferred.
Desired Education & Experience:
B.S. degree in Mechanical, Biomedical, or related Engineering discipline is required.
The candidate is expected to have a minimum of 8 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 necessary.
Strong project management and experience working with outside OEM and material suppliers, including managing budgets, timelines, design scope and manufacturing activities
Experience developing equipment and processes for high volume manufacturing
Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes.
Experience participating in cross-functional teams.
Experience participating in NPD design transfer to manufacturing.
- Up to 20% 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