Electrical Engineering Manager
Our client in Worcester, MA is looking for an Electrical Engineering Manager. The Electrical Engineering Manager will lead the electrical and software engineering product development team. We develop complex electro-mechanical medical devices.
- Inspire, lead, organize and manage internal and external electrical and software engineering team that must meet changing requirements and diverse advanced technologies to serve our medical customers’ time to market demands, patient safety requirements, and compliance obligations.
- Manage in a transparent manner, lead by example, and promote practical electrical and software engineering best practices.
- With strong collaboration among all department leaders, provide technical leadership to the organization with a focus on design engineering.
- Maintain positive, high performance environment that fosters extraordinary customer satisfaction and associate retention.
- Recommend improvements to and maintain compliance to the Quality System, 21 CFR 820.30, and ISO 13485.
- Design, draft and mitigate Risk Management for software and electrical hardware product designs.
- Participate in internal and external FDA, ISO 13485, and customer audits as required.
- Provide leadership in design to meet global product safety standards.
- Lead and develop the electrical engineering team resources, engineering core competency, budget, and individual program performance metrics.
- Oversee electrical and software engineering execution of multiple complex projects from design, prototype, pilot production and transition to manufacturing.
- Establish Best Practices and Policies consistent with company goals and objectives in an open and collaborative manner.
- Reinforce and encourage company core values.
- Provide professional and technical assistance and guidance to associates and customers.
- Support the development of detailed proposals and SOW’s for electrical and software engineering services.
- Lead and execute software engineering compliant to software design controls.
- Lead and execute electrical engineering compliant to medical device product safety regulations such as IEC 60601-1 and EMC safety regulations such as IEC 61000-x-x.
- Positive attitude, excellent communications skills, self-motivator, tenacious follow up, and superior organization skills.
- Superior customer service attitude.
- BS Degree in electrical engineering. MS preferred.
- Minimum of 10 years of experience in medical device product development required.
- Direct experience working within design controls (21 CFR 820.30) processes required.
- Excellent negotiation, problem solving, and written and oral communication skills, including experience presenting to customers and internal senior management.
- Excellent organizational skills with a commitment to meeting deadlines and expectations while ensuring overall compliance and quality of delivery.
- Excellent technical, problem solving and analytical abilities.
- Strong quality mindset a must.
- Must be flexible, possess strong leadership and interpersonal communication skills; ability to manage multiple priorities.
- Strong decision making capabilities and capacity to handle confidential information.
- Experience in phase gate product development required.
- A demonstrated commitment to company values.
- Proficient in Microsoft Office.
- Proficient with OrCAD schematic capture. PADS PCB layout is a plus.
- Proficient in C, C++, Visual C++, Basic, Visual Basic, Assembler software languages.
- Proficient in Windows, Windows CE, Unix operating systems.
- Proficient in RS232, USB, I2C, SPI, Parallel Bus protocols.
- Proficient in analog and digital circuit design, FPGA’s, Embedded Control Systems, High Voltage, Power Supply circuits.
- Laser experience is a plus.