The Hardware Engineering Manager leads and executes sustaining projects and coordinates task assignments of the engineering staff across the sustaining & development projects within R&D’s Sustaining Engineering Department. The Manager ensures all hardware engineering projects, initiatives, and processes are in conformance with established policies and procedures. The position is highly technical in nature and the applicant must have solid product sustaining engineering experience and background. The Manager will directly manage a staff of 7-10 FTEs, including electrical & mechanical engineers, technicians & support staff. The position reports to the Director of Sustaining Engineering who oversees all sustaining activities.
The projects will include a mix of product line extensions, limited new product and/or accessory development but mostly involves sustaining engineering releases of existing products. Typical sustaining projects include end-of-life component & material replacements, quality & reliability enhancements, limited cost reduction efforts, and production tooling lifecycle projects.
The Manager reviews and approves design concepts, design modifications, testing, verification strategies, and SOPs. They develop and motivate the electrical and mechanical engineering resources to form multi-disciplined electro-mechanical, design, and quality teams, in addition to involvement and coordination at system level with software development teams. They plan, develop and ensure that the department can provide the needed skill sets and resources to support the development and sustaining products within the resuscitation and acute critical care environments.
- Lead the planning and execution of product sustaining projects in accordance with established processes and procedures:
- Collaborate with Project Managers on various mechanical and electrical designs to assess task breakdown, resource needs and schedule requirements. Assist with detailed project plan development.
- Execute project plans, managing to cost and schedule commitments.
- Meet with individual engineers to track assignments and progress, provide technical mentoring, review, and oversight.
- Ensure product designs and design revision maintain product quality
- Perform tactical resource planning and matching of resources to assignments.
- Provide administrative management to a group of 7-10 technical professionals, including electrical & mechanical engineers and technicians.
- Mentor, coach and advise staff in career development and coordinate training.
- Track and administer time-off requests.
- Assess employee performance; author and deliver performance reviews and manage employee performance.
- Assist Director with departmental budget/expenditure planning and tracking.
- Assist staff with logistics support, vendor interaction, and departmental improvements.
- Provide appropriate cross-functional interdepartmental support of Manufacturing, Procurement, Quality, Assurance, Service, and Regulatory Affairs.
- Review technical specifications, design documentation, verification test plans, reports that support electrical & mechanical designs, design modifications, and their implementations.
- Lead hardware design reviews for hardware designs and modifications and associated risk management activities.
- Drive, oversee and perform Root Cause Analysis of product, production and/or quality issues.
- Perform and oversee engineers’ analysis of regression testing required as a result of design changes and enhancements.
- Manage the generation or maintenance of all Design History File and required project documentation, including product requirements, design documentation, requirements, and risk traceability documentation.
- Manage and/or assist project managers with technical partners’ and vendors’ supporting product/project execution activities.
- Effectively utilize problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities at the system level.
- Demonstrate excellent interpersonal, communication and negotiation skills with all levels of personnel, management and external suppliers and development partners.
- Review manufacturing and customer issues to plan and prioritize technical responses.
- Some travel (< 20%) will be required, including interacting with other corporate offices, customers, vendors, and test facilities.
Required/Preferred Education and Experience:
- Working knowledge of standards and regulations for Medical Devices, including Design Controls, Risk Management, and appropriate Electrical, Mechanical and Environmental Safety standards.
- Technical experience and expertise across a spectrum of electrical & mechanical engineering, including plastic injection molding, analog and digital design, PCB development, communication protocols, EMC and environmental standards testing.
- Experience collaborating with other project managers & other disciplines on projects outside core area of expertise.
- Lifecycle Project implementation experience in a regulated industry setting, including the ability to interpret and apply international safety and performance standards (e.g., IEC 60601, FCC, and IPC).
- Ability to arbitrate and resolve potentially conflicting electrical, mechanical and software development requirements at the system level.
- Demonstrated understanding of electrical, mechanical, and software engineering practices at the system level.
- Demonstrated aptitude for successfully managing multiple projects of varying complexity, within the agreed upon guidelines, time frames and budget targets.
- Ability to handle confidential employee and business information with appropriate discretion and security.
- BS degree in Electrical or Mechanical Engineering (Advanced degree preferred).
- 15+ years’ combined experience as a sustaining, hardware, or system engineer executing and/or managing sustaining tasks and projects within a highly regulated technical environment such as medical devices is required.
- Experience with sustaining engineering of medical devices is highly preferred.
- Minimum 2 years’ direct managerial experience of technical professionals is required.