Sr Electrical Engineering Manager

About company

Its a 90 person company and growing. They develop a LVAD leftventricle 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.

Note

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 EEs for their team this year.

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 crossfunctional 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 lifesaving 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 costeffective 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 bachelors 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 costeffective scaling of medical products.
• Indepth understanding of safety standards and risk management practices in the medical device industry.
• Excellent communication skills with the ability to effectively collaborate with crossfunctional teams and stakeholders.
• Strong problemsolving abilities with a focus on creating innovative and practical solutions.
• Ability to thrive in a fastpaced startup environment with a focus on delivering highquality results under tight deadlines.