Software Project Manager (medical device or robotics Must) at Apexon

Position: Software Project Manager (medical device or robotics Must)

Location: Sunnyvale, CA

• Must Have : Med Tech experience, Design Control experience and 21 CFR experience is a must have.
• Candidate should have knowledge on regulatory like ISO 13485, IEC 62304 and ISO 14971
• Software Project Manager with Product development experience
• Onsite Working: 3 Days onsite - Mon / Tue Thu. Should accommodate few Onsite Business Critical meeting on other days.

Job Title: Software Project Manager

Qualifications:

1. Bachelor’s or Master’s degree in Computer Science, Engineering, or related technical discipline.
2. 5+ years of project management experience in software development, with at least 2-3 years in medical device or robotics.
3. Proven track record leading software projects for medical devices, preferably surgical robotics.
4. Solid understanding of software development methodologies (Agile, Waterfall, Hybrid).
5. Familiarity with surgical robotic platforms, control software, integration with hardware systems, and surgical workflow.
6. Strong knowledge of regulatory requirements for medical software (IEC 62304, ISO 14971, FDA regulations).
7. Exceptional communication, leadership, and organizational skills.
8. Project Management Professional (PMP) or equivalent certification preferred.
9. Experience with project management tools (JIRA, MS Project, Confluence, etc.).