Job description
About This Role
Position Overview
This Senior Lead Engineer 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.
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.
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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.
Required Skill Profession
Engineers
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