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Senior Lead Engineer; Microaire

Job in Indiana, Indiana County, Pennsylvania, 15705, USA
Listing for: MicroAire Surgical Instruments, LLC.
Full Time position
Listed on 2025-12-06
Job specializations:
  • Engineering
    Mechanical Engineer, Product Engineer
Job Description & How to Apply Below
Position: Senior Lead Engineer (Microaire)
Location: Indiana
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 Solid Works (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 Solid Works (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…
Position Requirements
10+ Years work experience
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