Job Description SummaryWith the BD and Bard integration, we are designing and constructing a Medication Delivery Solutions (MDS) R&D organization with the functional capabilities, operating mechanisms, and organizational alignment to support our now-expanded existing business and to deliver the innovation and new products that our customers and stakeholders are counting on.
Success of our business is dependent on our ability to effectively address the sophistication and complexity of our customers’ needs in a robust, reliable, and consistent manner.To accomplish this transformation, we are establishing a VMSI R&D organization built around five key pillars – Architecture & Innovation; Systems Engineering & V&V; Design & Development, R&D Operations, Infrastructure & Continuous Improvement.
The VMSI R&D Operations, Infrastructure and Continuous Improvement organization (OIC) organization ensures the health and vitality of our organizational infrastructure (including Labs and Tools), shared services, business management processes, and drives Continuous Improvement initiatives focused on driving R&D Operational efficiency and productivity across the VMSI organization.The position will be responsible for developing and managing key VMSI R&D operational processes including (but not limited to) communications, business practices, ensure the maintenance and development of our global infrastructure (physical space, laboratories), working with the MDS Lean team to ensure the right tools are in place for our staff, and drive excellence in execution for our shared services such as test execution in our laboratories.Job DescriptionKEY RESPONSIBILITIESThis key role is responsible for leading all test execution, data analysis, and reporting for V&V activities across the VMSI businesses (excluding Intelliport).
This includes both new product development and sustaining engineering.
The Manager, TEDAR, is accountable to deliver high quality design verification and validation data analysis and reports.
The Manager and team are expected to deliver test results and reports that meet committed project delivery timelines established by the business.
The Manager will also be responsible for ensuring that data analysis techniques utilize state-of-the-art test approaches and tools.
The Manager and team will stay current regarding industry test standards for all products in the VMSI organizations.
In addition, the Manager and team will contribute to the successful automation of test method execution, where appropriate, working closely with the Lean Engineering organization within R&D.The Manager will leverage both skill sets within MDS as well as develop and acquire talent with new skill sets as needed.
The Manager will also ensure technical excellence in test method execution, data analysis, and reporting.
The Manager must also be highly hands-on in ensuring executional success.Specific Responsibilities:Lead the VMSI V&V test execution, data analysis, and reporting R&D team.Develop a world class data analysis and reporting team; coach, mentor, manage, and develop talent to achieve successful testing of medical devices.Partner closely with the Test Method Development team to ensure that test methods and protocols are well understood and that data analysis approaches fully address the intent of the methods to test product requirementsEnsure strong understanding of customer needs and clinical use of products within the TEDAR organization; provide opportunities for team members to experience customer usage of products.Ensure development of (and adherence to) best practices for component testing, design verification, and design validation.Collaborate with other Platform Engineering R&D leaders including system engineering, test method development, design & development, and design assurance.Maintain effective communication with the VMSI R&D leadership team, team leaders and members, and functional leadership in all activities required to successfully complete V&V testing.Drive innovation within the TEDAR organization to include advancing state-of-the art in data analysis and reporting that enhances efficiencies and delivers high quality test results.PROFESSIONAL EXPERIENCEThe successful candidate will have a proven record of verification and validation leadership in the medical device industry with a minimum of 8 years of experience.
S/he should be well-versed and experienced with the execution of all aspects of medical device product development including design, development, verification, and validation and other topics relevant to medical device product commercialization.
The Manager should feel comfortable dealing with ambiguity and be confident in applying engineering experience to lead teams through pragmatic choices about test execution, data analysis and reporting.
The candidate must be a self-starter and have a strong work ethic.
Experience as a creative problem solver, a passion for continuous improvement, and the ability to work independently and within a team setting are all required attributes.The successful candidate will have a reputation and record of effective collaboration with peers, subordinates, and superiors as well as outside advisors and customers.
S/he should also have a demonstrable history of attracting, developing, and empowering technical talent, with an emphasis on building engineering competencies and technical excellence.
Experience conducting testing, analyzing & interpreting data, and preparing V&V reports for medical products are expected.The candidate will have earned an undergraduate degree, preferably in engineering or physical sciences.
An advanced degree is advantageous.Required Knowledge, Skills, and Attributes:Successful track record of conducting V&V testing for medical device products, including analyzing & interpreting results and preparing reports.Deep understanding of disciplined medical device product development through phase-gate processes, including regulatory and quality requirements, particularly for design verification and validation.Technical organizational development, including a strong track record of attracting, mentoring, developing, and empowering technical talent.
Demonstrated use of R&D organizational tools, processes, standards and metrics, including establishment of best practices.Experience in design verification and validation for medical devices.
Experience in engineering disciplines including mechanical, biomedical, electrical, and/or software engineering.Demonstrated customer focus and engagement as related to design verification and validation.
Successful interaction with diverse external partners and stakeholders.Exceptional written and oral communication skills required.Demonstrated ability to develop innovative ideas to solve complex problems and reduce them to practice.Budget development, organizational planning, resource planning and hiring.Self-initiator, results driven, and action and detail oriented.Knowledge of Specific Procedures/Practices DesiredKnowledge of medical device industry regulations and practices.Hands-on design control experience.Ability to work independently.Disciplined and well organized.Demonstrated learning agility for new subject matter.Six sigma approaches for problem solving and root cause investigations.Minimum QualificationsBS degree in Engineering discipline, MS preferred.8 years of engineering experience including hands-on V&V test execution, data analysis and reporting as well as V&V managerial leadership.Primary Work LocationUSA NJ - Franklin LakesAdditional LocationsWork Shift Full time