Ximedica is an ISO 13485 certified and FDA registered full-service product development firm with offices in Providence, Minneapolis, San Francisco, Silicon Valley and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.
We have a high-energy collaborative culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.
Position: The experienced Electrical Engineering Manager supports our rapidly growing domestic and international product development, sourcing, and manufacturing business.
Nature of Role: Reporting to the Ximedica Director of Software and Electrical Engineering, the Electrical Engineering Manager is responsible for planning, implementing and maintaining costs, methods and employees related to the development of electrical hardware.
The manager is a key leadership position. In addition to leading the Electrical Engineering team, the manager is responsible for development of electrical hardware in products. This may include: medical and non-medical products and/or automated testing / manufacturing equipment used to build them, the hardware development process, testing, the evaluation of new technology and tools. As appropriate, the manager will also ensure compliance with medical device regulations and device standards in this regulated industry. The manager will oversee a group of professional electrical engineers and technicians while participating in technical work.
Requirements: An effective leader preferably holding a MSEE degree coupled with 10+ years of electrical engineering experience within the medical device/equipment industry. Possess a solid background in the design, manufacturing and sourcing of electrical components. The ability to prototype, simulate, debug, and test circuits is required. 4 + years leading, supervising, or managing engineers. Strong hardware development skills from requirements development through manufacturing support are necessary. Knowledge of FDA QSR Regulations (21 CFR 820), ISO 13485:2003 (Quality System) and ISO 14971:2007 (Risk Management) is essential.
Our fast-paced environment demands the ability to manage multiple projects within the discipline and deadlines. High-energy, self-starters with the following qualities:
- Successful communication skills, business acumen and assertive decision-making ability
- Flexibility to multi-task and perform a wide range of activities
- Excellent computer skills, including MS Office proficiency
The manager is responsible for advising teams and following Ximedica’s processes and procedures related to hardware development, including but not limited to:
- Leads and mentors electrical engineers while providing employee development and teambuilding
- Responsible for managing the capacity of the electrical engineering department
- Works with the Director of Engineering and Human Resources to identify suitable candidates
- Responsible for final selection of candidates for hire
- Works within the resource management process to identify and resolve gaps in capacity
- Acts as independent reviewer at key points in programs, including technical reviews (code reviews), design reviews, phase reviews and risk management reviews and advising on potential corrective action.
- Ensures adherence to established development policies and procedures, targeting reproducible and high quality output by participating in the overall program and development process.
- Advises proposal authors on scope of work and level of effort required for hardware related activities.
- Further advises Program Management on schedules and risks which may affect delivery timetables
- Works with the Director of Engineering to determine a department budget and execution of personnel training and tool inventory to ensure proper discipline capability
- Responsible for performance appraisals of electrical engineering personnel; works with Human Resources to make disciplinary decisions
- Creates individual professional development plans aligned with Ximedica's growth and business direction
- Employs/applies/develops standard development methodology and best practices
- Responsible for recommending, implementing and/or overseeing new technologies to insure Ximedica is a leader in hardware development.
- Maintain duties and responsibilities of a Senior Electrical Engineer as a percentage of overall workload.
Please send resume to: [email protected]