Senior Design Engineer
Job Description SummaryThe associate will be responsible for supporting the verification strategy creation and execution to deliver high-volume single use disposable medical products. This dynamic role will have you working with cross-functional engineering teams to guide products through verification using BD’s Stage Gate framework, DFM/DFSS to deliver cost-effective design-transfer. The successful candidate will support test method development activities encompassing measurement system development & analysis, test fixture design and equipment hardware/software validation for 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 multi-functional design verification and design validation activities. The successful candidate will support associates supporting requirements management, design and development and post-launch support.
- Define, plan and lead activities for test method & measurement system development and validation, and testing optimization in support of Design Verification.
- Lead creation and execution of verification protocols, summarize results, enable formal design reviews, and own the verification portion of the Design History File.
- Demonstrate proficiency in spotting Design Variance through relevant statistical measures.
- Follow Design Control & ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures.
- Interpret and analyze design verification data with respect to product performance and operational stability in the manufacturing plants.
- The associate will work on receipt, preparation, testing, and delivery of test samples and support materials for all V&V lab associate testing including sample inventory management.
- 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 cross-functional teams to ensure product requirements are verifiable and measurable.
- Synthesize, develop, update, and optimize designs based on understanding design space. Understand design options and tradeoffs; managing critical parameters; leverage strong engineering fundamentals and tools. Incorporate manufacturing principles early in the development process.
- Executes Continuous Improvement projects in the following (but not limited to) areas.
- Equipment or method troubleshooting/repairs.
- Coordinates with Test Method Development and Verification & Validation team for equipment and method validations
- Method or Equipment Upgrades
- Fixture maintenance
- Drawing or Specification modifications
- Responsible for Complete end to end maintenance of test equipment and management of Test method validation records.
- Ensure deliverables are reliable across 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 to drive informed 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.
- Actively build on personal skills, expertise, and competencies. Ensure that technical lessons are reviewed, learned, and disseminated.
- Coach and mentor junior engineers and technicians to execute project deliverables.
- Ensure compliance with BD quality policies, procedures, and practices.
- Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures.
- The incumbent will also be responsible for ensuring QMS conformance and ensure that the quality policy and objectives are met per organizational guidelines.
- Coordinate the Material Shipment & Vendor management.
Education and Experience:
Bachelor’s degree in mechanical or biomedical Engineering with 5 to 8 years of experience in medical device or other regulated industry OR
Master’s degree in mechanical or biomedical Engineering and 4+ years of experience.
Knowledge and Skills:
- Expertise with test method development, validation strategy, and execution is required.
- Expertise in fixture design & development.
- Expertise with design verification & validation strategy development and execution is required.
- Strong track record of technical problem solving and effective product development through expert application of engineering principles is required.
- Design controls expertise and experience with traditional and modern fabrication techniques is required.
- Proven experience in leading CAPAs, design-defect analyses, managing non conformances and remediation is required.
- Proficiency in solid mechanics/mechanics of materials and proficiency statistical methods/tools is required.
- Experience with design standard methodologies, including advanced tolerance design, and design for reliability.
- Experience and Knowledge on Medical regulatory standards
- Experience in solid modeling (SolidWorks) or electromechanical systems is a plus.
- Experience in high-volume manufacturing processes is a plus.
- Experience developing and commercializing medical devices is a plus.
- Exposure to Chemistry/ Chemical Engineering and/or structural analysis and simulation/mathematical modeling desirable.
- DFSS training or certifications are a plus.
- Ability to lead and teach others to assess project/program needs, formulate strategy, build support, and execute initiatives.
- Strong interpersonal and decision-making skills and the ability to effectively manage change and uncertainty.
- Ability to engage and mentor team members and to maximize diverse perspectives to achieve the best outcomes.