**Job Description Summary** The R&D team is seeking a highly talented and passionate individual to help us identify and implement innovative solutions to address current and future health care needs in the Peripheral Vascular Access (PIVC) markets. Within BD Medication Delivery Solutions (MDS) Research & Development, the associate in this position will be part of the PIVC Lifecycle Management R&D team. This Senior Staff R&D Engineer is responsible for developing and implementing innovative product improvements, and critical component changes for high volume, disposable medical devices. This engineer will also be accountable for developing workstream’s to educate and train our diverse engineering team. The preferred candidate will have strong technical design skills, excellent written and oral skills, leadership abilities and a track record of successful product design and development, along with lifecycle management of aging product lines. This candidate should possess 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. Other duties and responsibilities include but are not limited to the following: Technical Product Design: • Drive the design and development of product systems, subsystem and components by understanding design space with design options and tradeoffs, handling critical parameters, using design for manufacture principles as well as geometric dimensioning and tolerancing tools. • Integrate product systems and sub-systems to meet business objectives by addressing targeted customer needs and product requirements under defined cost targets. • Identify the best tools and approaches to effectively solve engineering problems to develop and optimize designs by using an appropriate mix of first principles / analytical, computational and experimental methods. • Ensure implementation and difficulty of product development processes and design control procedures. • Support the evaluation and assessment of new technologies, intellectual property, products, processes and industry trends that can or have the potential to impact our business strategies. • Support current products in terms of quality, manufacturing, supply continuity and cost improvement. • Support the execution of technical and/or multi-functional project work. • Contribute to a culture of innovation by proactively generating novel concepts for new products and improvements to current product performance. • Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies. • Translate customer needs into engineering requirements into specific product, packaging and process specifications. • Analyze design solutions using engineering first principles and sophisticated engineering methods such as FEA. • Write detailed technical reports based on design verification analysis/testing for design changes and product design activities. • Develop and implement test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis. • Develop realistic and actionable design plans. Project and Cross-Functional Leadership: • RD Point of Contact for any technical support needs for our manufacturing sites. • Technical leader for any marketing competitive assessments and strategy around claim’s and intended use creation. • Technical leader on addressing customer inquiries around product performance and intended uses. • Demonstrate cross functional and collaborative leadership with strong accountability for successful completion of team goals and business objectives. • Develop deliverables, schedules and demonstrate accountability for successful completion of individual and team work. • Ensure efficient and effective transition from product development to high volume manufacturing in locations throughout the world. • Effectively collaborate with laboratory technicians and support staff. • Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures. Organizational Development: • Managing the PLM team’s innovation process and gate keeper on phase review’s. • Proactively develop, maintain and share technical knowledge in specialized area(s), remaining up-to-date on current trends and standard methodologies. • Actively mentor and empower team members and junior associates, while also ensuring effective multi-functional communication and engagement. • Develop and apply innovative ways to ensure the effective capture, retention, communication and sharing of technical and project knowledge generated (tacit & implicit). Desired Qualifications: • BS degree in Engineering (Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering or a closely related engineering degree) required. A Master’s degree in engineering is preferred. • 8+ years of engineering experience or equivalent is required with a strong preference for least 2 years product design and development experience in medical devices / products. • Medical device design and development experience related to high-volume manufacturing is strongly preferred. • Strong interpersonal and influencing skills. • Advanced technical judgment. • Strong communication skills. • Collaborative and team oriented. • Significant understanding of disciplined product development processes, regulatory, and quality requirements. • Strong fit and alignment with BD values. Experience to include: • Demonstrated ability to deliver robust and successful products by following a disciplined design process such as Design for Six Sigma. • Demonstrated ability to apply statistical tools, computer analysis and engineering fundamentals to support sound engineering judgment. Experience with Solidworks, Minitab, and FEA (Abaqus / Fluent) is preferred. • Experience in developing project and technical development plans. • Design control experience. • Experience writing invention disclosures, patent applications, patents, and publications. • Developed understanding of DOE and statistical methods. • 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 **Job Description** We are **the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a **maker of possible** with us. **Job Summary** Senior Staff Engineer, PIVC Product Development Engineering will be responsible for developing new product solutions in the areas of Pre-Infusion products including pre-infusion systems (PIV) and accessories. The ideal candidate should have experience in medical device design with emphasis on injection molding, mechanical components and assemblies. The position requires the ability to identify innovative solutions to customer needs while balancing constraints related to cost, manufacturability, quality, safety and time to market. This role reports into Director of PIVC Design Engineering and works closely with a multi-functional team of engineers, scientists, researchers, and business partners. **Responsibilities** + Identify unmet clinical needs through observation, literature review and customer feedback + Develop conceptual designs based on understanding of clinical need and technical feasibility + Create detailed design specifications + Lead product development activities to bring products to market + Work with multi-functional teams such as product management, industrial design, biomedical engineering, regulatory affairs, quality assurance, manufacturing and supply chain to develop product requirements, specifications, prototypes and documentation + Conduct experiments to evaluate product performance + Present work to internal partners and customers + Contribute to intellectual property generation + Ensure compliance with all applicable regulations and standards + Maintain knowledge of state-of-the art technology in area of responsibility **Required Qualifications** + Education: Bachelor’s degree or higher in Mechanical Engineering, Materials Science, Biomedical Engineering or equivalent field required; Master's preferred + Experience: Bachelors Degree with minimum 6+ years of relevant experience in medical device industry, with focus on plastic injection molded products, mechanical design, and component/subassembly specification writing + Shown ability to identify customer needs and translate them into technical requirements + Ability to create detailed design specifications + Knowledge of materials science and mechanical properties + Expertise in plastics injection molding process and tooling + Experience using modeling tools such as SolidWorks, Pro/E, or similar software + Proficiency in FMEA analysis and risk management techniques + Familiarity with ISO10993 and ISO13485 biocompatibility testing standards + Ability to read and understand drawings and schematics + Strong communication skills and ability to present sophisticated information clearly + Team player who enjoys working collaboratively with others + Ability to travel up to 25% per year **Preferred Qualifications:** + Expertise in pre-infusion systems, specifically those used in peripherally inserted central catheterization + Familiarity with mechanical component specification writing + Knowledge of human factors considerations + Experience with injection molding defect prevention + Familiarity with ISO14971 risk management principles + Knowledge of drug delivery system design, particularly in the context of syringe pumps and other fluid handling mechanisms + Knowledge & Skills: Experience in pre-infusion systems and other infusion therapy devices strongly preferred For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace 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 encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit  https://bd.com/careers 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. **Primary Work Location** USA UT - Sandy **Additional Locations** **Work Shift** 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.