Sr. Design Engineer

Overview

Lead test method and measurement system development, validation and design verification activities for medical devices, and own the verification portion of the Design History File.

What you'll do

• Define, plan and lead activities for test method and 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 and 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.
• Work on receipt, preparation, testing, and delivery of test samples and support materials for all V&V lab testing, including sample inventory management.
• Apply engineering first principles and advanced engineering methods to understand underlying technical issues, and propose and implement robust solutions.
• Collaborate with Design and Development, Systems Engineering and cross-functional teams to ensure product requirements are verifiable and measurable.
• Synthesize, develop, update, and optimize designs based on understanding of the design space, design options and tradeoffs, managing critical parameters, and incorporate manufacturing principles early in development.
• Execute Continuous Improvement projects, including equipment or method troubleshooting and repairs, coordination with Test Method Development and Verification and Validation teams, method or equipment upgrades, fixture maintenance, and drawing or specification modifications.
• Be 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 and 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 design selection and development, using empirical, statistical, and analytical tools to drive informed design decisions and reduce design iteration cycle times.
• Ensure design considerations embed all applicable DFX aspects including manufacturability, usability, reliability, and safety.
• Create and document novel test methodologies and provide feedback and recommendations for product or design changes.
• Build on personal skills, expertise, and competencies, and ensure 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, practices, and QMS conformance, and that quality policy and objectives are met.
• Coordinate material shipment and vendor management.

What you'll need

• 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.
• Expertise with test method development, validation strategy, and execution.
• Expertise in fixture design and development.
• Expertise with design verification and validation strategy development and execution.
• Strong track record of technical problem solving and effective product development through expert application of engineering principles.
• Design controls expertise and experience with traditional and modern fabrication techniques.
• Proven experience in leading CAPAs, design-defect analyses, managing non-conformances and remediation.
• Proficiency in solid mechanics, mechanics of materials and statistical methods and tools.
• Experience with design standard methodologies, including advanced tolerance design and design for reliability.
• Experience and knowledge of medical regulatory standards.

Nice to have

• Experience in solid modeling (SolidWorks) or electromechanical systems.
• Experience in high-volume manufacturing processes.
• Experience developing and commercializing medical devices.
• Exposure to chemistry or chemical engineering and/or structural analysis and simulation or mathematical modeling.
• DFSS training or certifications.
• Ability to lead and teach others to assess project and 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 maximize diverse perspectives to achieve the best outcomes.

Details

• Primary work location: Bengaluru, India (Technology Campus).