Manager, Mechanical Engineering
$148,700–$297,300 year
On-siteAlameda, California, United States
Job Summary
Lead the functional management of Mechanical Engineering groups focused on developing innovative medical devices and systems from concept through commercialization. Provide technical leadership for design, analysis, testing, and validation activities while driving Design for Manufacturing, Assembly, Reliability, and Serviceability principles. Manage project plans, resource allocation, and engineering change orders to ensure deliverables meet scope, schedule, quality, and cost objectives. Collaborate with cross-functional teams including Quality, Regulatory Affairs, and Manufacturing to resolve complex mechanical challenges and ensure compliance with FDA regulations and ISO standards. Mentor team members and establish technical direction for new product platforms and major initiatives.
Required Qualifications
- Bachelor's Degree in Mechanical Engineering
- 12+ years of experience in mechanical design engineering
- minimum of 3 years in an engineering management or technical leadership role
- Strong technical experience in Mechanical engineering
- excellent written and verbal communication skills
- Experience working in a development environment with a disciplined development process for very quality sensitive applications
- Experience in writing product requirements and design specifications
- Experience in working on a development team with an emphasis on minimizing time to market
- Experience in design for manufacture for high-quality medical products
- Experience working in team environments
Desired Qualifications
- Master's degree or PhD or DSc
- Experience in designing medical devices in an FDA regulated environment
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