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R&D Systems Integration Engineering Manager

Company: Becton Dickinson
Location: Franklin Lakes
Posted on: May 16, 2022

Job Description:

Responsibilities Job Description Summary Job Description Be part of something bigger BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. As a member of the BD Pharmaceutical Advanced Drug Delivery Systems (ADDS) business, you will have the unique opportunity to play a vital role in the rapid scale-up of an exciting new business platform that will be a key contributor to BD's future growth. Our mission is to become a world-class, customer focused organization that will have a significant impact in improving how patients receive drugs for chronic conditions. You will have the advantage of combining the best of both worlds: the agility and creativity of a high-growth, start-up environment, and the backing and resources of a Fortune 500 company. This team member should share our passion for excellence and innovation while actively building on their motivation to design and build this family of self-administered injection products from the ground up. The new hire will join a New Product Development team and will be responsible for leading and/or participating in the design and development activities from concept all the way through commercial launch of the product with a focus on system engineering objectives. Activities will focus on identifying, articulating, and quantifying customer needs and requirements; translating these requirements to product requirements and specifications; assessing the suitability of current designs and technologies to meet these requirements; and, where necessary, developing and implementing innovative design solutions to address needs or gaps. More specifically your responsibilities will be to: Manage the system integration process to identify, communicate, and mitigate verification and validation risks throughout the product development effort Be an integral part of a team in aspects of innovation, design, and development and identify new technologies for a variety of advanced drug delivery products such as wearable injectors in a design control environment. Leverage and direct internal and external resources to maximize their effectiveness and provides analysis to leadership teams for resource planning. Lead activities associated with the verification and validation of a system to ensure robust design, and efficient architecture. Define, clarify, and document requirements; performing the necessary parametric analysis and tradeoffs; recognizing when interface impacts might occur and taking early action to avoid problems to increase design maturity Utilize quantitative approaches to design activities, system and technology integration, and have strong capabilities and experience in systems engineering and diversified interdisciplinary experience and knowledge. Work as part of a cross-functional team that collaborates with external partners, develops and manages requirements, generates system and component concepts, implements the solutions, performs experiments, analyzes data, and ensures robust verification and validation testing. Act independently within team expectations, providing guidance, training and work direction assignments to less experienced team members; coordinate with functional leadership to identify associates to complete tasks under his/her accountability while balancing a high level of autonomy in daily activities. Contribute to knowledge generation activities associated with the development and refinement of medical device design concepts, taking into consideration such things as industrial design, ergonomics, material selection, fits and tolerances, risk management, reliability, ease of manufacture, and cost effectiveness. Design objectives achieved through expertise in: Concept generation Functional modeling System architecting Prototyping (proof of principle) Customer requirement gathering Analyze and draw conclusions from test data for improving product performance Participate in technical and design reviews, risk analysis/management, and design verification/validation programs Generate imaginative yet practical technical solutions to a wide range of challenging problems. Exhibit an understanding of customer needs and processes to ensure relevant and innovative product development solutions. Demonstrate technical rigor and creativity, continuous learning and improvement, and alignment to customer needs and value creation. Demonstrate strong and clear accountability/responsibility for successful and timely completion of designated tasks. Contribute to a culture of innovation by proactively generating novel ideas to improve operational effectiveness as well as product performance through product enhancements that increase ability to address customer needs. Education and Required Experience: Minimum of 10 years' experience as a systems engineer and/or product design / development engineer and/or project engineer in the medical device or pharmaceutical industries or other regulated industry (experience with FDA class II or III medical devices preferred). Bachelors degree in Systems, Mechanical, Materials Science, or Biomedical Engineering or closely related discipline. Masters of PhD preferred. Experience with developing products or implementing product changes through a structured, phase-gated, product development process Experience leading strategy development, planning, and execution of verification and validation activities Demonstrated experience with all phases of the Design Control process. Key Areas of Expertise Experience providing technical expertise to the Systems Engineering Team and cross-functional project teams to support development and submission objectives Documented previous contributions to best-in-class systems engineering process functional excellence, including data-driven approach with focus on superior user experience Build functional excellence in front end of V-model (customer needs, intended use, design input requirements and system level design) by maintaining extensive knowledge of state-of-the-art principles, theories, and practices. Build functional excellence in back end of V-model (design verification and validation activities) to show how design inputs have been meet through project technical activities Promote the Systems engineering function and serve as a driver for the application of a systems-oriented focus to all Pharmaceutical Systems development teams and partners. Generate, review and analyze system design input requirements, applicable regulatory standards, functional decomposition, requirements writing, allocation and traceability, and systems concept of operations to ensure high quality work and compliance to BD operating system Develop and execute informal (engineering) and formal (design verification) test protocols. Summarize, communicate findings to drive decision-making amongst cross functional team and iterate on the design Establishment of criteria and methodologies for verification and validation of CTQs and all product requirements to agreed to level of product reliability Organize and lead technical reviews to determine maturity of design and required next steps to advance knowledge of critical design parameters Identify (through a variety of methods, including observation and solicitation), articulate, and prioritize customer needs and requirements Utilize understanding of product development considerations and best practices for traditional and modern fabrication techniques including complex systems of components made from high volume fabrication methods such as plastic injection molding, die casting, compression molding, etc. Utilize understanding of product development considerations and best practices for tightly controlled high-volume manufacturing processes. Understand requirements management process, with demonstrated experience in design verification and validation strategy and implementation. Utilize experience in a technical role on a cross-functional product development team, including technical leadership of medium to large R&D workstreams to complete project objectives Utilize understanding of medical device product development risk management methodologies such as FMEAs, Fault Tree Analysis, Event Tree Analysis. Show proficiency with statistical data analysis techniques and Design for Six Sigma methodologies Demonstrated ability to clearly and effectively communicate (verbal & written) concepts. Additional Assets: Ability to write protocols and reports for integrated system verification and validation testing Understanding of IP considerations Exposure to Human factors engineering (preferably in the medical space) including user studies and usability documentation Intellectual curiosity coupled with strong analytical and problem-solving skills. Demonstrated versatility and learning agility. Design and execution of user studies in support of product requirement specification development. Experience with high-volume manufacturing methods such as plastic injection molding and automated assembly/packaging processes. Experience with design optimization for multi-component mechanical assemblies or systems involving injection molded and compression molded components. Use understanding of fixture design including basic machining considerations and CAD modeling, and Measurement Systems Analysis (MSA) to oversee the development and qualification of test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements. For certain roles at BD, employment sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why join us? A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. To learn more about BD visit 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, or any other protected status. PDN Primary Work LocationUSA NJ - Franklin Lakes Additional Locations Work Shift Apply Save Job PDN-95ea64be-fea8-4d79-941f-c51bcfa3e698

Keywords: Becton Dickinson, New York , R&D Systems Integration Engineering Manager, Executive , Franklin Lakes, New York

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