Lead a dedicated team of embedded software developers in Boston, remote locations, and with third-party development partners in introducing new products, enhancing existing systems, and maintaining our client's products utilized in Transfusion, Hemostasis Management, and Plasma areas. Serve as a proficient hands-on technologist while also overseeing the day-to-day operations of a robust portfolio of medically regulated mission-critical embedded software products. Demonstrate strong interpersonal skills collaborating with Software and Hardware Engineers, Requirement Leads, Business Unit liaisons, Marketing, Regulatory, and Quality organizations. Take charge of product development plans, resources, budgets, and schedules. Mentor and guide a diverse group of software and user experience engineers in lean/agile development processes within the regulated medical device industry. Work closely with product owners to grasp market needs and visions, translating them into tangible software solutions. Drive efficiency improvements, eliminate duplication, and leverage product and technology reuse across teams. Additionally, support process enhancements to streamline development, maintenance, and support activities.

Technical Leadership

Demonstrate accountability to Business Units and Cross-functional organizations by articulating and managing overall technical capabilities for software on our client's hardware systems. Evaluate design alternatives and formulate consolidated architecture to establish a multi-year technology roadmap. Provide guidance to simplify complex design and architectural challenges. Exhibit expertise in hardware/software connectivity and cybersecurity related to embedded software challenges.

Customer Focus

Rapidly familiarize yourself with the customer landscape and the involved product portfolio. Align current and future product architecture with customer needs. Stay informed about changes in the transfusion, hemostasis management, and plasma market spaces, offering valuable recommendations to R&D and Commercial partners.

Domain And Functional Expertise

Effectively manage product requirements in collaboration with product leads, ensuring a clear understanding of upcoming product releases and future plans for the product portfolio. Maintain and update relevant standard operating procedures (SOP) for embedded software development, ensuring compliance with 62304 standards.

Day-to-day Execution

Oversee and guide product development activities, including team structure, workload, talent management, resource alignment, capacity planning, technical challenges, and tracking group deliverables.

Manage Metrics

Utilize appropriate tools, including those related to CI/CD pipelines, to monitor and report metrics on team productivity and the quality of outcomes.

Vendor Management

Engage current and future development partners to address day-to-day software development tasks such as coding, testing, and documentation, strategically filling any gaps as needed.

Schedule, Budget & Quality

Take sole responsibility for delivering software releases on time, within budget, and meeting expected quality standards.

Supervisory Responsibilities

Manage and lead a group of Software Development teams.

Qualifications

Bachelor's degree in Computer Science or Engineering Master's degree preferred (MS in Computer Science or MBA) Experience Requirements

Minimum of 15 years of experience in medical device embedded software development Experience leading large software development teams for 5-7 years Experience with tools such as JIRA, CI/CD pipeline tools & Scripting, QT, C, C , C#, Linux, RTOS uCOS Proficiency

Ability to manage a technical team while also providing technical guidance and contribution (Player/Coach model) Experience working within cross-functional product development teams Strong continuous improvement mindset and behavior preferred Technical proficiency with our client's technical stack including Linux, QT, C, C , or other relevant technologies Training/Certifications

Cybersecurity certifications Programming Language Certification (Java, C#)