BD (Becton, Dickinson and Company) Senior Engineer, V&V in Franklin Lakes, New Jersey
Job Description SummaryAt BD, we continually innovate to provide viable solutions to our customers’ changing needs across the healthcare continuum. Within Medication Delivery Solutions (MDS), we are focused on improving effectiveness, efficiency and safety of healthcare delivery and clinical outcomes. Our unique business environment which combines the agility and creativity of a fast-growing, start-up environment, and the backing and resources of a Fortune 500 company serves as an accelerator for Innovation and New Product Development.
Our R&D team is looking for highly talented and driven individuals with a real passion for product development and providing solutions to unmet clinical needs. In this new role, the successful candidate will have the opportunity to make impactful contributions and take on increasing responsibilities while working as part of a cross-functional and multi-disciplinary team. He/she will be responsible for evaluation of design options in development and also verification and validation of the finalized designs for new products or when a change to the existing portfolio is needed. In this role, the successful candidate will have the opportunity to rapidly broaden his/her knowledge of Product Development, gain exposure to a diverse product portfolio and learn about BD’s processes, while working in a dynamic cross-functional business environment.
Our engineers have a passion for identifying and bringing new technical solutions to fruition to address fundamental health care needs. Our associates pride themselves on technical excellence, personal commitment and achievement, and meaningful, lasting contributions to a collaborative team. As an organization, we aim to provide each associate with opportunities to acquire and share skills and knowledge, understand and deliver customer-driven solutions, and to work in an environment of mutual respect and continuous growth and development.
BD MDS (Medication Delivery Solutions) is seeking a highly talented and passionate individual to help identify innovative solutions to address current and future health care needs in the medication delivery markets. The available position is for a Senior Engineer with great potential for growth. The successful candidate will join the Verification & Validation team.
In this role, the associate will be accountable for the successful completion of Design Verification and Design Validation (V&V) activities for the assigned Product Development projects. More specifically he/she will be responsible for determining viable design evaluation strategies and putting them into action, collecting outputs and analyzing data, interpreting and reporting out results. Responsibilities may also include design and development of measurement systems to evaluate the proposed designs and also qualification of these systems.
Working within a cross-functional team the associate will be responsible for technical deliverables and execution of activities pertinent to V&V as described in the phase-gated of the product development process including design and development planning, requirements definition, product development, root cause analysis, test method development, and design verification/validation and appropriate documentation of these activities. Additionally, the candidate will be expected to participate in the development of new technologies for evaluation of products that will help meet current and future clinical unmet needs.
With minimal supervision, the successful candidate will be primarily responsible for supporting design evaluation activities during development and leading Design Verification and Validation to help meet key business objectives. Day-to-day responsibilities may include the following as well as other duties as required:
Initiate V&V plans and contribute to project plans/timelines
Provide viable options for evaluation of concepts with quick turn-around
Participate in risk management activities
Lead or participate in clinical evaluations such as user studies and design validation
Develop and establish Design Verification and Validation plans and protocols
Conduct technical assessment of design inputs. Propose viable verification strategies (e.g. engineering assessment, empirical or analytical methods).
Create and implement new design verification methodologies, modify existing ones to meet needs. Qualify developed measurement systems/methods appropriate for their intended use.
Apply core engineering and scientific principles during planning, execution, reporting of V&V activities. Leverage Six Sigma (DMAIC), and Design for Six Sigma (DFSS) principles to reach reliable and robust results
Solve technical problems using systematic problem-solving and statistical methodologies.
Investigate root cause of issues and propose solutions
Collaborate with SMEs within and external to BD to provide best in class solutions
Stay current with latest trends in medical device verification and validation strategies
Participate in design review and technical reviews. Lead when appropriate.
Represent company in external technical committees, conferences, meetings
Prior experience (minimum 5 years with a BS degree) working in medical device or other regulated industry. At a minimum, must have a Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or closely a related discipline; Master’s degree preferred
Basic understanding of the requirements management process (e.g. customer requirements vs. product requirements vs. product specification) as well as elements of Design Controls
Experience with collecting, recording, and interpreting data. Ability to use data with practical assumptions and engineering justifications
Working knowledge of analytical techniques to break complex problems into component parts.
Working knowledge of statistical analysis methods, and able to use programs such as Minitab to reach valid conclusions / decisions based on results
Demonstrated ability to write technical statements in a clear and concise manner, which convey information appropriately for a variety of audiences.
Effective Communication Skills - Ability to convey ideas confidently and succinctly in groups.
Persistency and drive to meet objectives within deadlines. Ability to adapt to change.
Exhibit all BD Values, e.g. Diversity and Respect - Respects individual differences and utilizes diverse thinking and contributions of everyone.
Experience and proficiency in computer based systems, Microsoft Office software (Outlook, Word, Excel, PowerPoint, etc.), and 3D CAD modeling software (e.g. SolidWorks)
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