BD (Becton, Dickinson and Company) Engineer II 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 delivering solutions to complex problems. In this new role, the successful candidate will have the opportunity to make impactful contributions by changing the status-quo and help improve lives of countless patients all over the world. With support from a cross-functional and multi-disciplinary team, the incumbent will be responsible for Shelf Life Verification of a diverse product portfolio. He/she will develop and implement a new process to help accelerate product development while still meeting customer expectations, regulatory requirements, appropriate voluntary standards, and BD policies and procedures. 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.More specifically, the associate filling this role will contribute to design verification activities required for the commercialization of various types of new and revised medical device products used in drug delivery. The role is uniquely positioned to support a diverse portfolio of products.
The successful candidate will be responsible for developing alternative strategies for the confirmation of a device’s shelf life. Working as part of a cross-functional team, the incumbent will lead an initiative develop and implement a new Shelf Life Verification Program. Additionally, the candidate may be expected to participate in the development of new technologies for testing products that will help meet current and future clinical unmet needs.
With minimal supervision, The successful candidate will be primarily responsible for developing and implementing a viable strategy for the Shelf Verification Program to help meet key business objectives with emphasis on efficiency and effectiveness, risk reduction and impact.
Specific responsibilities will include the following as well as other duties as assigned:
Establish key strategic objectives for the Shelf Life Verification program
Identify stakeholders of the process, and define their needs and requirements
Define all other factors critical for success, including
Potential risks and risk mitigation
Interactions with other processes
Required process inputs and outputs and their usability
Critical process steps and required tools
Process measurement, monitoring and analysis, and corrective and preventive actions
Improvement and innovation
Develop a viable and optimized Shelf Life Verification process to meet objectives
Establish a workflow and define input and outputs and controls for each step
Obtain feedback from stakeholders and validate assumptions
Ensure when fully implemented process addresses all critical objectives, maximizes impact and benefit to the business, improve efficiency while maintaining compliance
Plan for the implementation of the changes by determining resource needs, clarifying roles and responsibilities of individuals, determining tools required for successful execution, and training requirements such that all identified objectives are met by the process.
Understand the strategic plan of the organization and the impact of individual and team contributions.
Champion continuous improvement as a business opportunity using supporting data
Ensure sufficient process health is maintained, and establish metrics and controls for indicators that are critical for success and quality of outputs, and publish reports
Actively build on personal skills, expertise, and competencies. Ensure that technical learnings are passed on to team. Actively engage in formal and informal written and verbal communication within the team and with the rest of the organization to ensure dissemination of important information and learnings.
Resolve technical problems effectively and efficiently. This will require identification/creation of solutions using systematic problem-solving and statistical methodologies and application of engineering first principles as well as advanced engineering methods to gain deep understanding of the underlying technical issues, and to propose and implement robust solutions.
Ensure compliance with all applicable regulatory requirements and guidelines
Additionally, the incumbent will contribute to Design Verification strategies in Product Development. He/she will at the minimum be expected to successfully:
Collaborate with internal and/or external Develop an overarching strategy that can be applied to various types of products, their functional characteristics, materials and requirements
Ensure employed verification methodologies are robust and appropriate
Help develop tools and a data repository to store learned knowledge
Apply this knowledge to future projects to optimize DV strategy and minimize risk, enable critical decision
Ensure cross-functional support with careful consideration to regulatory requirements
The successful candidate will also oversee execution of any on-going Shelf Life Design Verification activities. At a minimum, he/she will be expected to
Apply statistical analysis methods using commercially available statistical analysis software to reach conclusions / decisions and provide recommendations
Propose viable solutions to encountered challenges and problems by applying engineering principles and input from SMEs and other sources, as needed, to encountered problems and propose viable solutions. Use unconventional approaches to solve problems where standard approaches don’t work.
Write, review and approve technical protocols and reports to document findings
Provide creative and thoughtful input to improve processes, methods, and products. Ensure successful implementation of above mentioned process improvements and any other incremental changes necessary to meet objectives
Selectively examine and absorb a large amount of diverse data.
Prior experience (1-5 years) working in medical device or 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
Experience with collecting, recording, and interpreting data. Ability to use data with practical assumptions and engineering justifications to assists in design, development and analysis of products and systems
Working knowledge of statistical analysis methods, and able to use programs such as Minitab and Microsoft Excel to reach valid conclusions / decisions based on results
Working knowledge of analytical techniques to break complex problems into component parts.
Experience with verification of form, fit and function product changes through a structured, phase-gated, product development process.
Basic understanding of the requirements management process (e.g. customer requirements vs. product requirements vs. product specification).
Experience in technical role on a cross-functional team, ideally in Product Development and Medical Device industry Ability to write technical statements in a clear and concise manner, which convey information appropriately for a variety of audiences.
Ability to initiate and implement change. Ability to execute to an overall plan
Ability to prioritize and act with required sense of urgency - Clearly identifies and communicates the level of urgency / priority the situation or need demands. Keeps required individuals informed and involves them appropriately in making decisions.
Drive for results with emphasis on process effectiveness, continuous versatile learning, customer focus, and team work.
Effective Communication Skills - Ability to convey ideas confidently and succinctly in groups. Communicates clearly, clarifies and extends the meaning of others’ points for mutual understanding. Keeps others informed in a timely manner, and works to gain consensus of individuals to the benefit of the organization.
Persistency and driven to meet objectives within deadlines but flexible, adapt to new information.
Exhibit all BD Values, e.g. Diversity and Respect - Respects individual differences and utilizes diverse thinking and contributions of everyone.
Growth - Maintains adequate qualifications, and focuses development in areas pertinent to current role
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