Sr. Software Project Manager SnS

About the Role

Key Responsibilities

• 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.
• Absorb the care coordination and patient monitoring domain, and 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.
• Work 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 Integrity, Innovation, Accountability, and Teamwork.
• Report quality problems or defects to management for corrective action.

Requirements

• 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.
• 2+ years' experience with hosting applications in cloud environments such as AWS, Azure, or Google Cloud.
• 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.
• Effective leadership, communication, and presentation skills.
• Must be able to work in the U.S. without visa sponsorship.

Nice to Have

• Experience coordinating team members in US, Europe and India.

Qualifications

• Bachelor of Science degree in a relevant engineering or scientific discipline.
• Extensive experience in software development and project management within medical device or healthcare industries.

Benefits & Perks

• Please review our benefits here: Life at OSI.
• The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location and date of hire.
• Salaries are based upon candidate experience and qualifications, as well as market and business considerations.