Senior Staff R&D Engineer
4 weeks ago
Job Description Summary
The R&D team at BD is seeking a highly skilled and passionate individual to help us identify and implement innovative solutions to address current and future healthcare needs in the Peripheral Vascular Access markets.
As a Senior Staff R&D Engineer, you will be part of the Vascular Access Device R&D team within BD Medication Delivery Solutions (MDS) Research & Development.
Our team is responsible for making significant contributions to the successful product design, development, and commercialization of medical device products that improve the safe delivery of IV therapies.
The ideal candidate will have strong technical design skills, excellent written and oral communication skills, leadership abilities, and a track record of successful product design and development.
This role requires a strong capability to interpret and ensure compliance with all local, state, federal, and BD safety regulations, quality policies, best practices, and procedures through appropriate communication, training, and education.
Responsibilities:
- Develop project schedules and demonstrate strong accountability for successful completion of projects/programs and team deliverables
- Ensure efficient and effective transition from research to development to high-volume manufacturing in locations throughout the world
- Provide project leadership to cross-functional teams comprising QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing team members
- Deep understanding of the application of financial and business acumen, analysis, judgment, and decision-making in the management of the project and related responsibilities, including cash flow
- Effectively lead and direct the work of other engineers and laboratory technicians
Minimum Qualifications:
- BS degree in engineering (Mechanical, Biomedical, or related technical field) is required. A master's degree in engineering is strongly preferred.
- A minimum of 10 years of engineering experience is required.
- Medical device design and development experience related to high-volume manufacturing are strongly preferred.
Experience to include:
- Demonstrated ability to deliver robust products by following a disciplined design process such as Design for Six Sigma
- Demonstrated expertise in the use of statistical tools, computer analysis, and engineering fundamentals to support sound engineering judgment.
- Solidworks, Minitab, and FEA (Abaqus / Fluent) experience is preferred.
- Project leadership and management experience
- Experience in developing business cases and integrated project plans
- Strong track record in new product development is required while experience in product development for the medical device industry is highly desirable
- Demonstrated expertise in design control
- Experience writing invention disclosures, patent applications, patents, and publications
- Strong understanding of Design of Experiments (DOE) and statistical methods.
- Formal training and experience in Design for Six Sigma (DFSS) methodology or probabilistic design approaches is a strong advantage
- Strong understanding of failure theory and modes for plastics, elastomers, and metals due to static and time-variable loading conditions
- Experience with clinical studies, human physiology, and simulated product use studies.
- Experience with contact and non-contact metrology
- Knowledge of high-volume manufacturing and assembly processes, particularly those of plastic injection molding, metal stamping, and automated assembly techniques, including solvent bonding, adhesive bonding, ultrasonic welding, and interference-fitting.
- Experience with manufacturing process validation including strategy development, First Article Inspection, Factory Acceptance Testing, and IQ/OQ/PQ's.
- Knowledge of disciplined product development processes, regulatory and quality requirements such as 21CFR820.30
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