Sr. Software Project Manager SnS
Spacelabs
- Snoqualmie, WA
- Permanent
- Full-time
- Deliver and manage all aspects of medical device software development project deliverables.
- Coordinate the backlog tasks and software project deliverables across all internal and 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 care coordination and patient monitoring domain, and be able to translate that knowledge into managing a detailed backlog of Features derived 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 the Software team to comprehend and execute.
- Generate, communicate, coordinate, and manage the documentation deliverables for the Document History File (DHF) consistent with meeting the needs and goals of the FDA and global regulatory agencies.
- Works in conjunction with the development technical lead and design quality assurance lead 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.
- Uphold the company's core values of Intergirty, Innovation, Accountability, and Teamwork.
- Demonstrate behavior consistent with the Company’s Code of Ethics.
- It is the responsbility of every employee to report to their manager or a memeber of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problems.
- Duties may be modified or assigned at any time to meet the needs of the business.
- Bachelor of Science degree in Computer Engineering or Computer Science, Mathematics or a related Engineering discipline.
- 12+ years’ experience delivering software product development projects from R&D to commercialization.
- 3+ years’ experience in medical device design and development. Expert familiarity with 21 CFR Part 820, ISO 14971, ISO 13485, and IEC 62304.
- 3+ years’ experience managing Agile software projects.
- 5+ years' previous hands-on development experience in an object-oriented software development environment is required (this role is not hands-on development but previous hands-on experience is a requirement).
- 2+ years’ experience with hosting applications in cloud environments such as AWS (preferred), Azure, or Google Cloud required.
- Experience in development of integrated (hardware and software) devices is a plus.
- Demonstrated experience with Git and Azure DevOps (ADO) as it applies to Agile project management and software development is a plus.
- Experience coordinating team members in US, Europe and India is a plus
- Effective leadership, communication, and presentation skills.
- Must be able to work in the U.S. without visa sponsorship (e.g. H-1B visa status).