Job ID R-304958
Job Description Summary
At BD Medical – Diabetes Care, a business unit of Becton Dickinson & Co., we are currently strengthening our core capabilities for product 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, and our Center of Excellence for Wearable Electro-mechanical Devices is located in Andover, MA.
We are looking for highly innovative, passionate, and talented individuals to join our R&D team, where you will have the opportunity to play an important role in the development of BD’s next generation of products for diabetes care. 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 Staff Mechanical Engineer wil help the team design, develop and commercialize new Diabetes Care products. This talented and passionate individual will be responsible for delivering innovative and practical solutions that support the product development road map. In addition to technical expertise, the Staff Mechanical Engineer will bring strong leadership and team building skills and foster an environment of growth and personal development.
Duties & Responsibilities
- Lead mechanical design of disposable and durable system items, including prototypes, tooling and test fixtures, and support development of manufacturing equipment and processes
- Lead efforts in creation of specifications and test methods for new products
- Work with upstream and downstream stakeholders to create designs that meet customer expectations and high-volume manufacturing requirements
- Use first principles and advanced engineering methods to guide the development process
- Perform 3D modeling and tolerance analysis of complex electromechanical systems
- Perform design reviews, FMEA’s, risk / hazard analysis, establish technical requirements
- Identify and qualify suppliers for specialty materials and equipment
Knowledge & Skills:
- Strong design skills with mechanical components and assemblies
- Demonstrated understanding of product development considerations for tightly controlled, high-volume manufacturing processes
- Clear understanding of product and process validation including V&V, TMV, FAI, FAT/SAT IQ/OQ/PQ etc.
- Excellent understanding of medical device product development risk management methodologies
- Knowledge of Design of Experiments (DOE), Design for Six Sigma (DFSS), Design for Manufacturing/Assembly (DFMA)
- Ability to clearly communicate ideas and knowledge (upward and downward) to other individuals and teams - both in writing and verbally
- Ability to manage competing simultaneous priorities effectively
- Basic understanding of IP considerations
- Expert capability with SolidWorks, use of GD&T a plus
Education & Experience:
- MS in Engineering (Mechanical preferred) with at least 5 years experience, or otherEngineeringdegree plus 8 years experience as a Mechanical product design / development engineer and/or project engineer in the medical device or pharmaceutical industries
- Completion of multiple projects within a structured Phase Gate development environment through all phases of the Design Control process
- Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes
- Experience designing components for high volume manufacturing processes, i.e. injection molding, extrusion, metal stamping
- Strong project management and experience working with outside design services, including managing budgets, timelines, design scope and manufacturing activities
- Proficiency with data acquisition, analysis and statistical techniques using Labview, MatLab, Minitab etc.
- Familiarity with materials used in medical devices (best practices, biocompatibility)
- Specialty technical expertise, such as materials related to medical plastics or lubricants, or the use of Computational Modeling and Simulation tools for fluid or structural/solid mechanics
- Experience designing small fluidic systems or pumps
- Hands-on ability to work on test method development, fixture development, prototype assembly, preliminary concept generation testing/evaluation
- Experience leading cross-functional teams
- Proficiency in Microsoft Project or equivalent project planning software
- Up to 10-15% domestic or international travel