Manager of Electromechanical Engineering

Location
Cleveland, OH
Category
Full-time
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Description

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.
Requirements

KNOWLEDGE AND SKILL REQUIREMENTS

Education:

Bachelor's degree in Electrical Engineering, Mechanical Engineering, Systems Engineering, or a related technical field. Master’s degree is preferred.

Experience:

  • 10+ years of experience in electromechanical product development, particularly in the medical device industry.
  • Proven track record of developing complex electromechanical systems and translating requirements into physical devices.
  • Significant experience in writing clear, comprehensive requirements and developing robust verification and validation plans.
  • Strong expertise in statistical tools and analysis for product optimization (e.g., DOE, regression analysis, etc.).
  • Familiarity with design for manufacturability (DFM) and design for reliability principles.

Skills & Competencies:

  • Deep knowledge of the full product development lifecycle, with expertise in systems engineering, integration, and testing.
  • Strong command of design assurance processes and regulatory requirements, including FDA guidelines, ISO 13485, and IEC 60601 standards.
  • Exceptional ability to write and document engineering requirements and specifications that drive robust and manufacturable designs.
  • Expertise in statistical analysis to guide product design, optimization, and decision-making.
  • Excellent communication skills, with the ability to clearly articulate technical concepts to both technical and non-technical stakeholders.
  • Experience with Class II and/or Class III medical devices
  • Ability to lead cross-functional teams while maintaining a hands-on approach to solving complex engineering challenges.
  • Strong technical skills in both mechanical and electrical engineering design, with experience in CAD software (e.g., SolidWorks, AutoCAD) and electrical design tools (e.g., Altium, PSpice) preferred.

WORKING CONDITIONS

  • Ability to “get the job done” in a we-can-do environment, allowing for flexible hours, depending upon the project and/or customer needs.
  • Small office environment (does own documentation and interacts directly with others in virtually all situations)
  • Travel will be minimal and can usually be well planned in advance.