About this role:
The Mechanical Engineer II is responsible for supporting the full lifecycle of product development, contributing to mechanical design efforts from initial concept through validation, productization, and release. The position involves creating and maintaining detailed design documentation, including drawings, 3D models, and risk assessments, while ensuring alignment with internal quality systems and project timelines. The ME II collaborates closely with cross-functional teams, customers, and suppliers to ensure designs meet manufacturability, serviceability, and performance requirements. The ME also supports troubleshooting, problem-solving, and continuous improvement initiatives across both new and existing products, while maintaining clear communication on development progress and technical considerations.
Must haves:- Experience developing new product designs across the product lifecycle (concept through validation and release)
- Experience in the medical device manufacturing industry or knowledge of injection molding design and related manufacturing processes
- Strong mechanical design capability including drawings and 3D modeling
- Experience with documentation such as risk assessments, development plans, and design records within a quality system
- Ability to manage timelines and support project schedules
- Experience working cross-functionally with internal teams, customers, and suppliers
- Problem-solving and continuous improvement experience on both new and existing products
- Familiarity with tools like CAD, ERP, and general business software
Nice to Have:- Exposure to regulated environments and formal quality systems (e.g., eQMS)
- Broader supplier interaction experience, including understanding manufacturing capabilities and troubleshooting processes
