Description

• Ability to plan and execute software projects in the medical device industry, with preferred experience in medical device software, including new product development and sustaining software.
• Working knowledge of the software development lifecycle (SDLC) in a regulated environment, with exposure to agile or hybrid delivery models.
• Proficiency with project management and software delivery tools (e.g., MS Project, JIRA), including development of WBS, schedules, and dependency tracking.
• Working understanding of software day to day challenges and system level integration, sufficient to support cross functional execution.
• Strong verbal and written communication skills, with the ability to collaborate across Software, Systems, Quality, and Regulatory teams and drive on time delivery.
• Demonstrated organizational and problem solving skills, with the ability to manage assigned scope and operate effectively within a regulated, quality driven environment.

Required Qualifications:
• Bachelor’s degree in engineering, Computer Science, or related technical discipline.
• Software Development experience 5 years minimum C#, WPF Minimum 5 yrs.. hands on development experience
• Web technology Experience 2 yrs prefered
• 10-15 years of experience in software project management within software driven medical devices or other regulated industries.
• Demonstrated experience leading cross functional software development programs.
• Strong understanding of regulated software development lifecycles and quality systems.
• Proven ability to manage complex, ambiguous programs with multiple stakeholders.

Preferred Qualifications:
• Familiarity with FDA, EU MDR, and global regulatory expectations for software enabled medical devices.
• Experience with cybersecurity, cloud connected devices.
• PMP, PgMP, Agile, or SAFe certification.
• Master’s degree in Engineering, Management, or related field

Key Skills

Education

Bachelor's or Master's degrees