Job Description / Intro
The Software Manager is responsible for MC10’s software and data products through managing an agile sprint process across a multi-disciplined software team. MC10's software engineering team consists of firmware engineers, mobile developers, cloud developers, and release and quality engineers. The software team builds and maintains a wearable technology platform that primarily includes the BioStamp nPoint system, which is a 510k regulated medical device used for physiological data collection in clinical research. The Software Manager will own the agile development process, oversee QMS/regulatory compliance, technically guide the team across disciplines, and close the gap between high level requests and implementation.
The ideal candidate has a strong engineering background in complex systems, is an effective and hands-on technical leader, and has proven success in managing teams, engineers, and process. This manager will continuously meet the needs of MC10’s quality system and regulatory requirements, while maintaining fast-paced code churn and rapid prototyping within the agile framework.
Collaborating closely with MC10’s marketing, clinical, quality and product development teams, the Software Manager will reliably deliver high quality and innovative solutions.
Roles and Responsibilities
- Manage an established 2-week sprint process, including leading sprint kickoff, grooming, planning, and review meetings
- Manage software release workflow ensuring delivery of high quality and well-documented product
- Gather internal and external input for product improvements, clarify and define scope of work, and disseminate to development team
- Technically contribute to feature definition, product workflows, system architecture, and product roadmap
- Define dependencies and interfaces among platform components, and guide implementation
- Collaborate with quality, regulatory, and marketing teams to help define product strategy and facilitate implementation
- Maintain software documentation and design history files to comply with MC10’s quality system (DHF includes product specifications, design documents, risk and cybersecurity assessment, outstanding anomalies, test procedures, and verification reports)
- Lead verification & validation efforts for software system, review and own documentation
- Track and respond to software complaints in the field and conduct risk and solution analysis
- Assist as software lead in customer, vendor, and regulatory audits
- Develop product and process improvements based on software best practices and agile methodology
- Verify regulatory compliance, audit development process, and provide guidance to accelerate software development within design control
Qualifications / Requirements
- BS/MS in computer science or electrical engineering
- Experience with IoT systems, connected devices, physiological data applications, data science, clinical research ecosystem
- Experience leading cross-functional, technical teams
- Expert in software development process
- Experience leading Agile development/Scrum process
- Experience with Jira Software and Atlassian tools
- Experience developing regulated technology, specializing in software systems and quality engineering
- Experience in V&V for regulated products
- Experiencing in Design History File preparation for regulatory submission
- Knowledge in ISO 13485 compliance
MC10 is a privately held company focused on improving human health through digital solutions. The company combines conformal BioStamp sensors with clinical analytics to unlock novel insights from physiological data collected from the home or in clinical settings. Our flagship product, BioStamp nPoint, is marketed into the clinical research community. MC10 is headquartered in Lexington, MA. We are looking for new employees who are passionate about improving the world and want to work in a fast-paced, team-oriented, highly collaborative work environment. For more information, visit MC10 online at mc10inc.com or follow us on LinkedIn.
Email email@example.com to apply.