Our smaller medical device client is adding a
Director of Electrical and Software Engineering to lead an engineering team in creating groundbreaking solutions. The Director of Electrical and Software Engineering will play a pivotal role in driving the development and implementation of electrical and software systems for innovative medical devices. This leadership position requires a seasoned professional with a proven track record in both electrical and software engineering, as well as a deep understanding of regulatory requirements within the medical device industry. He/she provides subject matter expertise and leadership for the design, development, and manufacture of company products. This person will work closely with senior management to create company and product strategies and lead subsequent tactical planning and execution. He/she leads internal electrical and software resources and external development services partners. He/she works with Regulatory Affairs personnel (internal or external) to determine appropriate regulations and monitor regulatory compliance. He/she works with national certified laboratories to ensure testing to the applicable IEC standards. He/she leads and facilitates compliance with appropriate quality system and regulatory requirements.
Your role with the company:
1) Leadership and Strategy
a) Provide strategic leadership for the electrical and software engineering teams, aligning their efforts with overall company goals.
b) Manage external design service organizations on the planning and execution of development programs and system manufacturing.
c) Mentor, develop and recruit a high-performing team of electrical and software engineers.
d) Foster a culture of innovation, collaboration, and continuous improvement within the engineering department.
e) Manage the budget for the electrical and software engineering team, ensuring efficient allocation of resources.
2) Cross-functional Collaboration
a) Collaborate closely with cross-functional teams, including marketing, quality assurance, regulatory affairs, and manufacturing, to ensure a cohesive and successful product development process.
3) Technical Oversight
a) Oversee the design, development, and testing of electrical and software components for medical devices, ensuring compliance with industry standards and regulatory requirements.
b) Implement best practices for electrical and software development, including version control, code reviews, and testing methodologies.
c) Interface with appropriate outside resources (testing agencies, design services, consultants, regulatory, customers, etc.) to ensure development programs meet regulatory, customer and product level requirements.
d) Evaluate and procure equipment necessary to test and manufacture product.
e) Provide input and review of product test plans and reports.
f) Support verification and validation testing
g) Support animal testing.
h) Contribute to the generation of companies intellectual property.
4) Design Controls
a) Develop and document test plan protocols, standard operating procedures, specifications, test methods, and other design history file documents.
b) Supports the development of quality documents for failure analysis, hazard analysis, design master records, etc.
5) Regulatory Compliance
a) Stay abreast of relevant regulations and standards in the medical device industry, ensuring that all electrical and software engineering activities comply with applicable requirements.
6) Risk Management
a) Identify and mitigate technical risks associated with electrical and software engineering activities.
b) Implement robust processes for risk management throughout the product development lifecycle.
7) Design Transfer and Operations
a) Manage design transfer to manufacturing and support development of manufacturing testing to ensure on-time delivery of product in full compliance with associated specifications.
b) Provide technical assistance for diagnosing manufacturing quality problems.
Desired Profile:
Bachelor's degree in Electrical Engineering, Software Engineering, or a related field. Advanced degree preferred.
Proven experience (minimum of 10 years) in a leadership role overseeing electrical and software engineering teams, in the medical device industry and/or in energy delivery applications, high frequency electro-surgical device experience. Pulse Field Ablation (PFA) a huge plus.
Strong knowledge of relevant regulations and standards, such as ISO 13485 and IEC 60601 (base, particular and collateral standards).
Demonstrated success in developing and launching complex medical devices.
Excellent interpersonal and communication skills. Ability to thrive in a fast-paced, startup environment.
