Sr. Manager, R&D - Verification and Validation
BD Medical – Diabetes Care is searching for a Sr. Manager, R&D - Verification and Validation to lead a team focused on product development of large complex new-to-world product development platforms that help people with diabetes live healthier lives. Scope includes new major initiatives or major product development programs within the Diabetes Care business unit or across multiple business units including Diabetes Care. We are recruiting for a highly driven technical manager with a passion for problem solving and a proven track record of successfully developing medical products. Reporting to the Associate Director, Innovation and New Product Development, the successful candidate has a unique opportunity to lead a high-caliber R&D team responsible for test method development, verification and validation in a growing business. The successful candidate will be responsible for leading product verification activities and will lead test method development activities, measurement system development & analyses, test fixture design and equipment hardware/software validation of measurement system equipment. He/she will ensure that translated product requirements are testable and measurable. The ideal candidate will also participate in executing technical and cross-functional project work, which includes all phases of product development, including design and development planning, requirements definition, product development, root cause analysis, test method development, design verification/validation and reliability.
Responsibilities include but not limited to the following:
- Define, plan and lead activities, including, test method & measurement system development and validation, fixture design and testing optimization in support of Design Verification.
- Participate in the planning and execution of technical project work. This will involve the application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues, and to propose and implement robust solutions.
- Collaborate with Design & Development, Systems Engineering and manage V&V Engineering teams to ensure that product requirements are testable and measurable.
- Critically evaluate and analyze system performance and reliability and ensure the design space is adequately pressure-tested to satisfy user, regulatory and business requirements. Understand system and subsystem design sensitivity and identify and address early any potential design integration and transfer risks.
- Implement DFSS rigor throughout the design selection and development process, leveraging and deploying empirical, statistical and analytical tools which will improve design decisions and reduce design iteration cycle times.
- Ensure the design considerations are embedding all applicable DFX (Design for Excellence) aspects including manufacturability, usability, reliability and safety.
- Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
- Synthesize, develop, update and optimize designs that meet requirements by understanding design space with design options and tradeoffs, managing critical parameters, leverage strong engineering fundamentals and tools and integrating manufacturing principles early in the development.
- Actively build on personal skills, expertise, and competencies. Ensure that technical lessons are reviewed, learned, and disseminated.
- Ensure compliance with BD quality policies, procedures, and practices.
- Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures
- Bachelor’s degree in Systems Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related field.
- 10 years of professional experience leading or supporting product development projects
- Six Sigma certification training / experience
- Design controls expertise
- Proficient in statistical methods / tools
- Experience with implementing product changes through a structured, phase-gated product development process
- Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions
- Leadership and team building skills
- Experience with design best practices, including design for reliability.
- Working with regulatory standards
- Strong project management skills
- Graduate degree (MS or PhD) in Engineering or related field
- 10+ years of post-educational experience in Medical Device Design highly desired
- Experience as lead in the development of medical disposable devices highly desired
- Pharmaceutical Infusion pump development experience
- Proficiency with statistical techniques including familiarity with Gage R&R, Reliability, analysis of variance (ANOVA) and design of experiment (DOE) methodologies highly desired
- Expertise in common risk management techniques highly desired
- Experience in electromechanical drug delivery or drug combination devices
- Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards highly desired
Knowledge, Skills and Abilities:
- Established expertise in leading engineering analysis to predict behavior of proposed designs with analysis tools based on analytical or computational methods (e.g. Minitab, Lab View).
- Broad and deep understanding of disciplined product development processes, regulatory, and quality requirements including design control. This includes understanding of phase gate process.
- Demonstrated deep understanding of establishing project and product requirements.
- Regulatory standards (ISO14971, ISO 13485), and system level V&V planning and execution.
- Knowledge of Design for Six Sigma (DFSS) methodology.
- Excellent verbal and writing skills
- Highly collaborative both within the function and with other functions
- Advanced technical and managerial judgment; advanced problem solving skills.
- Self-initiator, results driven and action & detail oriented.
- Disciplined and well organized.
- Demonstrated learning agility of new subject matter.
- Understanding and use of an innovation process utilizing elements of search, synthesis, and select.
- Strong passion for the diabetes epidemic and motivation to simplify the management of diabetes
- Ability to travel approximately 25% of the time, and international travel will be required.
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