The Opportunity:

Our team in Alameda, California currently have an opportunity for a Manager, Mechanical Engineering. This individual will be responsible for the functional leadership and management of one or more Mechanical Engineering groups focused on the development of innovative medical devices and systems. Provides technical and personnel leadership for engineering teams engaged in the design, analysis, testing, and commercialization of mechanical systems, components, and assemblies.

Responsible for resolving complex mechanical engineering challenges and setting the technical direction for mechanical design, advanced materials, manufacturing processes, and product development methodologies. Accomplishes this through leadership of the Mechanical Engineering team, development of engineering talent, and oversight of mechanical design and product development activities from concept through commercialization.

Leads the mechanical architecture and design strategy for new product platforms and major product development initiatives, ensuring robust, reliable, manufacturable, and cost-effective solutions. Identifies and evaluates new technologies, design methodologies, and engineering tools for potential implementation into current and future products.

Provides technical oversight and project leadership for mechanical engineering activities, including product design, analysis, prototyping, verification and validation testing, reliability engineering, and design transfer to manufacturing. Collaborates closely with Electrical Engineering, Quality, Regulatory Affairs, Manufacturing, and Supply Chain teams to ensure successful product development and commercialization.

Accountable for resource planning, talent development, engineering process improvement, and execution of project deliverables related to scope, schedule, quality, and cost objectives.

The ultimate goal of the Mechanical Engineering organization is the specification, design, development, testing, validation, and transfer to manufacturing of medical monitoring devices and related systems. All activities are conducted in compliance with applicable FDA regulations, ISO standards, and other U.S. and international medical device industry requirements, including Design Controls, Risk Management, and Quality System regulations.

What you will do:

·       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 the mechanical engineering expertise of the organization through coaching, mentoring, training, and the implementation of engineering best practices.

·       Responsible for the development and execution of 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 the development of new medical device products from concept through commercialization.

·       Apply advanced knowledge of mechanical engineering principles, including materials selection, mechanism design, structural analysis, thermal management, reliability engineering, manufacturability, and product lifecycle management.

·       As an individual contributor, participate in the development of product requirements, mechanical design specifications, risk assessments, and verification and validation protocols.

·       As an individual contributor, support project planning and scheduling activities to ensure successful execution of engineering deliverables.

·       Communicate effectively and 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, while contributing to reviews of electrical and system-level designs.

·       Author, review, and approve Engineering Change Orders (ECOs), design documentation, drawings, specifications, and technical reports as required.

·       Serve as an independent technical reviewer for projects and programs outside of direct team responsibility to ensure engineering rigor and compliance with company standards.

·       Responsible for ensuring team compliance with applicable regulatory and quality requirements.

·       Deliver high-quality mechanical engineering designs that meet performance, reliability, manufacturability, cost, and schedule objectives.

·       Lead, mentor, and coach mechanical engineering team members to ensure technical excellence, professional growth, accountability, 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 throughout the product development lifecycle.

·       Ensure delivery of product designs that 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 are conducted in accordance with approved Design Control procedures, FDA Quality System Regulations, ISO 13485 requirements, ISO 14971 risk management practices, and other applicable medical device industry standards and regulations.

Required Qualifications:

·       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 or DSc preferred.

·       Strong technical experience in Mechanical engineering with excellent written and verbal communication skills are essential.  

·       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 in designing medical devices in an FDA regulated environment is desirable.

·       Experience working in team environments is required.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.