Senior Lead Engineer
8 hours ago
Marmon Technologies India Private Limited
As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway— you'll be doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.
This Senior Lead Engineer for Microaire is responsible for providing technical leadership and direction across Sustaining and Innovation Engineering projects, overseeing design changes, product enhancements, and new solution development. This role drives complex problem-solving, mentors junior engineers, and ensures design integrity from concept to validation. Senior Lead Engineer partners with engineering leadership to define strategies for product improvement, cost optimization, and innovation while maintaining compliance with engineering standards and business objectives
Mandatory Skills:
- 5+ years' experience in driving execution of complex design changes including model and drawing revisions, design justifications, tolerance stack-ups, verification testing, and root cause analyses.
- 5+ years & Advanced proficiency in SolidWorks (or equivalent CAD software) for complex assemblies, tolerance stack-up analysis, and design optimization.
- 3 to 5 years' experience in deep understanding of GD&T per ANSI Y14.5, tolerance analysis, and mechanical stress evaluation for high-precision components.
- Strong communication & interpersonal skills and ability to work in a fast-paced environment and manage multiple priorities.
Desired Skills:
- Lead and oversee Change Request and Change Order processes, ensuring effective prioritization, technical accuracy, and cross-functional alignment.
- Drive execution of complex design changes including model and drawing revisions, design justifications, tolerance stack-ups, verification testing, and root cause analyses.
- Manage and approve design control documentation updates related to post-market activities, ensuring traceability through Risk Analysis, Product Trace Matrices, and Usability Engineering records.
- Provide technical oversight for regulatory support activities, including review of Technical Files, FDA notifications, and OUS market submissions to ensure design compliance.
- Partner with Product Innovation and Strategy teams to lead user evaluations, design validations, and technical feasibility studies for new or modified products.
- Mentor and guide the Design Verification team in developing and validating robust test methods, analyzing results, and ensuring design intent is fully verified.
- Collaborate with Manufacturing Engineering to oversee Design Transfer activities—ensuring design robustness, manufacturability, and adherence to quality standards.
- Engage and manage relationships with external partners and suppliers, providing technical direction for materials, components, and prototypes.
- Lead cross-functional collaboration with Quality, Regulatory, Project Management, and Testing teams to ensure timely completion of engineering deliverables and adherence to design control processes.
- Provide technical mentorship to junior engineers, fostering continuous improvement in design practices and documentation rigor.
- Advanced proficiency in SolidWorks (or equivalent CAD software) for complex assemblies, tolerance stack-up analysis, and design optimization.
- Deep understanding of GD&T per ANSI Y14.5, tolerance analysis, and mechanical stress evaluation for high-precision components.
- Expertise in designing and validating mechanical systems with strong understanding of materials, mechanical behavior, and manufacturing constraints.
- Strong knowledge of fabrication and process capabilities (machining, molding, casting, surface finishing) and their impact on design for manufacturability (DFM) and design for assembly (DFA).
- Understanding of lifecycle reliability factors such as corrosion resistance, fatigue, wear, and sterilization effects in reusable instruments.
- Experience leading Design Verification and Validation (DV&V), test method development, and data-driven design decisions.
- Comprehensive understanding of ISO 13485, ISO 14971, CFR 21 Part 820.30, and IEC 62366 requirements, with demonstrated application in product development and documentation.
- Experience supporting regulatory submissions (Technical Files, FDA notifications, OUS registrations) from a design perspective.
- Proven ability to lead cross-functional design reviews, mentor engineers, and guide design control documentation.
- Strong communication, presentation, and decision-making skills.
- High proficiency in MS Office, Project, and engineering software used for analysis and documentation.
- Demonstrated ability to manage multiple projects, set technical priorities, and ensure compliance with business and regulatory requirements
Opportunities for Growth
- Take ownership of cross-functional engineering and validation projects with exposure to medical systems aligned with U.S. norms.
- Deepen expertise in validation engineering, statistical data analysis, and workflow automation using Smartsheet, SharePoint, and ERP tools.
- Build leadership by mentoring junior engineers, improving processes, and driving data-based decision-making across global teams.
- Progress into senior roles such as Engineering Manager, or Technical Manager based on performance with leadership and mentoring opportunities.
Required Qualifications
- Graduation in Mechanical Engineering, (or equivalent work experience) with 8 -10 Years (Min 5 years of exp in projects working with US businesses, Medical device product development experience is added advantage)
- A seasoned, result-oriented engineer who can work independently once given direction, has good rapport with coworkers, can listen, be creative, and is detailed oriented.
- Strong analytical and problem-solving abilities with keen attention to detail, accuracy, and flexibility to adapt quickly to changing business needs and project priorities.
- Excellent communication and interpersonal skills, with the ability to convey technical information clearly, collaborate effectively across functions, and work both independently and in team leadership roles.
- Maintains a good attitude, persistence, and drive focused on finding a way to accomplish the objectives.
Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law .
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