Electrical Engineering Manager

Job Title: Sr. Electrical Engineering Manager

Location: Hybrid (3-Days Onsite per week) in Burlington, MA, 01803, Non local workable

Duration: Full-Time (FTE)

Interview process: Phone followed by Video Interview.

The person has to have extensive experience in the medical device development space, if they do not have at least 5 years experience with medical device, they are a pass. Their experience should include bringing new products to market. They will lead a team of 4 locally day one, then will play a big role in the hiring of 3 or 4 more EE's for their team this year. This could be a role that is a "step-up" position for someone, meaning if they are a technical lead or principal engineer that has mentored junior engineers, then they could make sense also.

They are onsite/hybrid 3 days (Tuesday-Thursday) in office, 2 from home.

They develop a LVAD left-ventricle assist device that helps people with heart issues to live longer. They are currently in clinical trials with very good results. A great time for someone to join their team.

Job Description-:

Our client is seeking a highly skilled and experienced Senior Electrical Engineering Manager to join its growing R&D team. In this pivotal role, you will lead the electrical engineering team responsible for the development of our technologies.

In this position, you will work closely with cross-functional teams including mechanical engineering, software engineering, regulatory affairs, quality assurance, and clinical teams to ensure the successful design, development, and commercialization of our products. Success in this role requires strong leadership, a deep technical background in electrical engineering, and a passion for advancing life-saving medical technologies.

Responsibilities

• Lead and mentor the electrical engineering team, fostering a collaborative and innovative environment that encourages technical excellence.
• Oversee the electrical design, development, and integration of electrical systems for mechanical circulatory support devices, including power management systems, communication modules, sensors, UI components, and alarm and feedback systems.
• Work closely with the product development team to define requirements, create design specifications, and ensure compliance with regulatory standards (e.g., FDA, IEC 60601).
• Manage the design, development, and verification of electrical subsystems, ensuring robustness, reliability, and safety for use in a medical setting.
• Direct the testing and validation of electrical systems to ensure performance meets clinical and regulatory requirements.
• Ensure that electrical designs are scalable and manufacturable, working with the operations team to streamline the design for cost-effective production.
• Provide technical guidance and oversight during all stages of product development, from concept through to commercialization.
• Actively participate in risk management processes, including dFMEA and fault analysis, to identify and mitigate electrical system risks.
• Collaborate with other engineering disciplines (mechanical, software, systems) to ensure seamless integration of electrical components into the overall system.
• Interface with our regulatory team to help support the submission process to obtain necessary approvals.
• Drive continuous improvement in design processes and product performance by staying current with emerging technologies and industry trends.

Requirements

• Minimum of a bachelor's degree in electrical engineering or related field.
• 8 years of experience in electrical engineering, with at least 3 years in a leadership or management role within the medical device or healthcare industry leading complex product development projects.
• Strong knowledge of electrical system design for medical devices, including battery management systems, sensors, wireless communication technologies, and embedded systems.
• Expertise in electrical design verification and validation, as well as regulatory requirements (e.g., FDA, IEC 60601, ISO 13485).
• Experience with circuit simulation tools, PCB design, design for manufacturability, and cost-effective scaling of medical products.
• In-depth understanding of safety standards and risk management practices in the medical device industry.
• Excellent communication skills with the ability to effectively collaborate with cross-functional teams and stakeholders.
• Strong problem-solving abilities, with a focus on creating innovative and practical solutions.
• Ability to thrive in a fast-paced, startup environment with a focus on delivering high-quality results under tight deadlines.

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