Overview
At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.
Role Overview
The Software Project Manager (Instrument SW) for the next generation patient monitoring platform will manage a global software engineering team using Agile methods for delivery of an exciting new patient monitoring system to the global healthcare market.
This position is responsible for the project management of software integrated into a new patient monitor instrument working closely with one or more development technical leads. This role requires an exceptional understanding of how to manage a software project through Agile software metrics and high interaction with the teams and program leaders. The role works very closely with other teams during the different development phases to integrate the hardware and software.
Must have experience managing software engineering product development projects, a proven track record of innovation, the ability to work cross-functionally with hardware, quality, systems, product management, and the ability to work collaboratively within several passionate software development teams. The position requires excellent communication skills with technical peers, customers, and executive management.
Responsibilities
* Deliver and manage all aspects of medical device software development project deliverables.
* Coordinate tasks and software project deliverables across all internal and outside contract resources, closely collaborating with the program management team.
* Manage project scope, schedule, resources, dependencies, and risks to schedule while focusing on timely delivery to milestones.
* Ability to absorb the patient monitoring domain, and be able to translate that knowledge into creating detailed backlog Features from requirements for the development teams to absorb and breakdown into work product on a sprint-to-sprint basis.
* Ensure Software and Product requirements are adequate for Software development team understanding and execution.
* Generate, communicate, coordinate, and manage the documentation deliverables for the Document History File (DHF) consistent with the needs and goals of the FDA and global regulatory agencies.
* Works in conjunction with the development technical lead and design quality assurance to follow a risk-based approach to project management with frequent design reviews to follow the Quality Management System.
* Work with cross-functional groups such as Electrical, Regulatory, Systems, Operations, Field Service, and Verification.
* Assign, track, and follow-up on various tasks removing obstacles hindering progress.
Qualifications
* Bachelor of Science degree in Computer Engineering or Computer Science, Mathematics, or a related Engineering discipline.
* 5+ years’ experience delivering hardware and software product development projects from R&D to commercialization.
* 3+ years’ experience managing Agile software projects.
* 5+ years' hands-on experience in an object-oriented language software development environment, a plus if in C++.
* Experience in development of integrated (hardware and software) medical devices is a plus.
* Experience in project management of medical devices under Design Control (21 CFR Part 820) and ISO 14971, and developing to and compliance with IEC62304 is a plus.
* Demonstrated experience with Azure DevOps (ADO) as it applies to Agile software development is a plus.
* Experience coordinating team members in US, Europe, and India is a plus.
* Excellent verbal, written, and listening skills – works well with engineers and other members of cross-functional team.
* Ability to use discretion, exercise good judgment, and resourcefulness.
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