Job Description Summary
Job DescriptionPosition Title
: Lead Lab EngineerDepartment
: R&DJob Group
: BD TCI, Bangalore, India
At BD, the Medication Delivery Solutions (MDS) business is comprised of the world leading products needed to safely prepare and administer medication, such as: Medication Delivery (Conventional and Safety hypodermic needles & syringes, Enteral/Oral syringes, Spinal & Epidural needles etc.,), Catheter Care (BD PosiFlush pre-filled syringes & ChloraPrep infection prevention products), Infusion Specialty Disposables products and Vascular Access Devices (VAD) products. MDS is focused on reducing complications, improving patient safety/outcomes, and lowering total cost of care around the world.
Within VAD business group, we are looking for a highly talented and driven individual with a passion and proven track record for product development and engineering. The incumbent will join VAD providing leadership and technical support to a large cross-functional team. The associate will be responsible for leading the verification strategy creation and execution to deliver high-volume single use disposable medical products. He will be responsible for end-to-end Lab Management activities for the platform. 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 lead test method development activities encompassing measurement system development & analyses, 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 leading requirements management, design and development and post-launch support. More specifically, your responsibilities will include:Key Responsibilities
- Define, plan and lead activities for test method & measurement system development and validation, fixture design and testing optimization in support of Design Verification.
- Lead end to end responsibility of all the platform level testing and Lab management
- 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.
- 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.
- Synthe, 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.
- 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.
Skills and Requirement
- Bachelor's Degree in Mechanical or Biomedical Engineering with minimum 9 years of experience in medical device or other regulated industryORMaster's Degree in Mechanical or Biomedical Engineering and 7+ years of experience
- Expertisewith test method development, validation strategy, and execution is required.
- 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, 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
- Working with 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 aplus
- Exposure to Chemistry/ Chemical Engineering and/or structural analysis and simulation/mathematical modeling desirable.
- DFSS training or certifications are a plus.
- Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions
- 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
- The incumbent will also be responsible for ensuring QMS conformance and ensure that the quality policy and objectives are met per organizational guidelines.
- Ability to lead and teach others to assess project/program needs, formulate strategy, build support, and execute initiatives.
- Strong interpersonal anddecision-makingskills 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.
- Responsible for leading, developing, and implementing critical component changes for high volume, disposable medical devices.
- Associate development: Actively develop and mentor associates. Provide frequent feedback. Continue to raise the bar on the group and help associates rise to expectations.
- Influence others: Intuitively and quickly assess people and situations and act accordingly. Demonstrate strong persuasion and timing skills. Remain open to be persuaded when appropriate.
- Inclusive work environment: Promote and leverage diversity to achieve best outcomes.
- Leadership courage: Demonstrate and promote leadership courage by doing what is right. Engage those who disagree to persuade or be persuaded. Instill confidence in associates and customers.
- Dealing with ambiguity: Demonstrate agility and action orientation when facing change and uncertainty. Effectively manage change and instill confidence.
- Analyze design solutions using engineering first principles and advanced engineering methods
- Write detailed technical reports based on design verification analysis/testing for design changes and product design activities
- Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis
Primary Work Location
IND Bangalore - Technology CampusAdditional Locations