Lead Engineer

Lead Engineer

CR Bard
9-12 years
Not Specified

Job Description

Job Description Summary
Job Description

Position Title : Lead Lab Engineer
Department : R&D
Job Group : JG3
Location : 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.
Preferred skills
  • 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
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About CR Bard

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

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