What are the responsibilities and job description for the Manager of Electromechanical Engineering position at SPR Therapeutics, Inc.?
Job Type
Full-time
Description
SUMMARY
Team Management & Development
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:
Full-time
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.
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.
- 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.
- 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.
- 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.
- 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.
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.
- 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.
- 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.
