Product Development Manager

We seek a hands-on Product Development Manager to lead team and driverequirements, scheduling, and coordination for our small, high-impact engineering team. This role combines classic product management with technical depth sufficient to translate complex engineering needs into clear requirements—critical for future FDA submission.

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Key Responsibilities

• Capture, document, and maintain detailed system requirements using tools such as Visure or equivalent.
• Break down features into actionable tasks and manage schedules for mechanical and software engineers.
• Facilitate cross-team communication and alignment between mechanical, software, and external contractors.
• Define verification and validation criteria tied to requirements.
• Establish early best practices and documentation standards in preparation forquality/regulatory processes.
• Track progress, identify risks, and adjust priorities in a fast-moving startup environment.
• Contribute technical insight during design discussions (optics, robotics, imaging).

Required Qualifications

• 10+ years in technical product management or systems engineering roles.
• Proven experience writing detailed requirements for hardware-software systems (ideallymedical devices or robotics).
• Proven track record in product development.
• Strong technical background—able to understand and discuss robotics, computer vision,optical systems, and embedded platforms.
• Proficiency with requirements management tools (Visure, Jama, DOORS, etc.).
• Excellent communication and facilitation skills in small teams.
• Experience in regulated environments (medical devices strongly preferred).

• Prior work in medical device development and familiarity with FDA 21 CFR 820 / ISO 13485.
• Background in computer vision or robotics projects.
• Agile/Scrum certification or equivalent practical experience.