The Manager of Electromechanical Engineering will be a key technical leader responsible for overseeing the design and development of electromechanical systems used in our medical devices.
This role requires a deep technical skillset, including expertise in mechanical and electrical design, systems engineering, and the ability to translate complex product requirements into robust, manufacturable devices.

PRIMARY RESPONSIBILITIES

Team Management & Development

Lead, guide, and mentor a team of engineers by providing technical direction and fostering a collaborative, high-performance work culture.
Balance management responsibilities with active, hands-on technical involvement to directly support the team in solving complex engineering challenges.
Ensure effective communication and alignment between team members and across functional areas to meet project milestones and objectives.
Work closely with external vendors and contract developers, overseeing the outsourced development of electromechanical components, sub-systems, and systems.
Provide technical support and guidance to internal employees and contract developers to ensure they adhere to project requirements and resolve issues as they arise.

Technical Design & Systems Engineering

Drive the integration of mechanical and electrical subsystems, ensuring seamless functionality and robust performance in final product designs.
Lead the writing of clear, precise, and comprehensive engineering requirements, ensuring they are traceable and effectively drive design decisions and verification activities.
Use statistical tools and analysis (e.g., design of experiments, regression analysis, etc.) to optimize product performance, reliability, and robustness.
Ensure that all engineering efforts translate into physical designs and design outputs that meet both functional specifications and manufacturability criteria.
Oversee the development of detailed design outputs, including schematics, CAD models, and specifications that are traceable to product requirements.

Design Output & Verification

Lead the development of test plans and verification protocols to ensure designs meet rigorous standards for performance, reliability, and safety.
Oversee the creation of product validation plans and ensure thorough documentation of all design verification activities.
Provide technical expertise during design reviews, offering insights and suggestions to ensure designs are robust, manufacturable, and meet all regulatory standards.

Design Assurance

Apply knowledge of design assurance principles (FDA, ISO 13485, IEC 60601) to ensure all products meet regulatory and quality standards.
Oversee the execution of risk management activities (FMEA, fault tree analysis) throughout the product development lifecycle.
Ensure that all design documentation is accurate, comprehensive, and meets the requirements of design control regulations.
Ensure traceability of design decisions from initial concept through final product delivery, ensuring all requirements are met, and deviations are managed appropriately.

Continuous Improvement & Innovation

Advocate for a data-driven approach to design improvement, leveraging statistical analysis and performance metrics to optimize product reliability and performance.
Monitor industry trends, emerging technologies, and best practices to inform the development of innovative solutions for next-generation devices.
Champion process improvements in product design and development to enhance efficiency, quality, and manufacturability.
Assumes other related duties as assigned.