Role Overview
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.
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).
Preferred Skills
- 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.
