Manager, Mechanical Engineering

About the role

Our team in Alameda, California is seeking a Manager, Mechanical Engineering. This individual will provide functional leadership and management for one or more Mechanical Engineering groups focused on developing innovative medical devices and systems. The role involves technical and personnel leadership for engineering teams engaged in the design, analysis, testing, and commercialization of mechanical systems, components, and assemblies. Responsibilities include resolving complex mechanical engineering challenges, setting technical direction, and overseeing product development from concept through commercialization.

Responsibilities

• Functional manager responsible for staffing, developing, and maintaining a high-performing Mechanical Engineering team with strong technical competency in product design, analysis, testing, and manufacturing support.
• Technical leader responsible for maintaining and enhancing mechanical engineering expertise through coaching, mentoring, training, and implementing engineering best practices.
• Develop and execute technical project plans and schedules covering all mechanical engineering activities, ensuring compliance with Design Controls, product development procedures, and applicable SOP requirements.
• Lead the mechanical engineering team in developing new medical device products from concept through commercialization, applying advanced knowledge of mechanical engineering principles.
• As an individual contributor, participate in developing product requirements, mechanical design specifications, risk assessments, and verification and validation protocols.
• Support project planning and scheduling activities to ensure successful execution of engineering deliverables.
• Collaborate with cross-functional teams including Electrical Engineering, Software Engineering, Systems Engineering, Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, and Program Management.
• Participate in and lead technical design reviews for mechanical systems, assemblies, components, manufacturing processes, and product requirements.
• Author, review, and approve Engineering Change Orders (ECOs), design documentation, drawings, specifications, and technical reports.
• Serve as an independent technical reviewer for projects outside of direct team responsibility to ensure engineering rigor and compliance with company standards.
• Ensure team compliance with applicable regulatory and quality requirements.
• Deliver high-quality mechanical engineering designs that meet performance, reliability, manufacturability, cost, and schedule objectives.
• Mentor and coach mechanical engineering team members to ensure technical excellence, professional growth, and disciplined application of engineering processes.
• Serve as a key technical gatekeeper for mechanical design quality, driving adherence to engineering standards, design controls, risk management practices, and verification requirements.
• Ensure product designs meet project technical requirements, cost targets, reliability goals, manufacturability objectives, and development timelines.
• Drive Design for Manufacturing (DFM), Design for Assembly (DFA), Design for Reliability (DFR), and Design for Serviceability principles throughout the development process.
• Oversee mechanical prototyping, verification testing, validation activities, tolerance analysis, design reviews, and transfer-to-manufacturing efforts.
• Ensure all product development activities comply with approved Design Control procedures, FDA Quality System Regulations, ISO 13485 requirements, ISO 14971 risk management practices, and other applicable medical device industry standards.

Requirements

• Bachelor's Degree in Mechanical Engineering with 12+ years of experience in mechanical design engineering, including a minimum of 3 years in an engineering management or technical leadership role.
• Master’s degree or PhD preferred.
• Strong technical experience in Mechanical Engineering with excellent written and verbal communication skills.
• Experience working in a development environment with a disciplined process for quality-sensitive applications.
• Experience writing product requirements and design specifications.
• Experience working on a development team with an emphasis on minimizing time to market.
• Experience in design for manufacture for high-quality medical products.
• Experience designing medical devices in an FDA-regulated environment is desirable.
• Experience working in team environments is required.

Pay

The base pay for this position is $148,700.00 – $297,300.00. In specific locations, the pay range may vary from the range posted.