Job title: Lead Engineer

Company: BD

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.
• 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.
• 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 industry OR Master’s Degree in Mechanical or Biomedical Engineering and 7+ years of experience
• Expertise with 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 a plus
• 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 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.

Leadership

• 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 Campus

Additional Locations

Work Shift

Expected salary:

Location: Bangalore, Karnataka

Job date: Wed, 06 Jul 2022 06:10:41 GMT

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