Senior Lead Engineer (Microaire)

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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 GDT 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 GDT 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 (DVV), 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 .