SUMMARY

• 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.