Project Manager (Full-time)
About The Position
About Pulsenmore
Pulsenmore is revolutionizing women's health through groundbreaking self-scanning ultrasound devices, enabling remote monitoring and diagnosis from the comfort of home. Our vision is to democratize access to high-quality care, empower women throughout their fertility and pregnancy journeys, and bridge the gap between home and clinic through cutting-edge telemedicine.
About Pulsenmore FC
Pulsenmore FC is a compact, hand-held transvaginal ultrasound probe that enables women undergoing fertility treatments — particularly IVF — to perform follicular scans at home. Guided by a mobile app and supported by remote medical review, the FC offers a safe, effective, and convenient alternative to frequent in-clinic monitoring during ovarian stimulation. By reducing the burden of travel and making care more accessible and discreet, the FC empowers women to take control of their fertility journey while maintaining close medical supervision.
About the role
We’re looking for a passionate and visionary Project Manager to lead the evolution of Pulsenmore FC. You'll collaborate with multi-disciplinary teams to translate user needs, clinical protocols, SW and HW requirements, strategic business goals into an exceptional digital-physical product and shape the experience of women using the device. You will lead the entire project development lifecycle of the Pulsenmore FC and future products, conduct design reviews, transfer to production, and perform post market surveillance.
This role sits at the intersection of digital healthcare, and women’s empowerment.
Responsibilities
- Project Management: Collaborate with development teams and manage projects for new and existing company products under the design control methodology.
- ECO Support: Manage and support all activities related to Engineering Change Orders (ECO) for software releases, hardware changes, and manufacturing processes updates, ensuring compliance with regulatory standards.
- Lead pFMEA: Conduct process Failure Mode Effect Analysis periodically to improve efficiency and conformance in the R&D department and manufacturing processes.
- Documentation: Create and maintain comprehensive project documentation for the Design History File (DHF), ensuring accuracy and completeness.
- Technical Writing: Develop clear and concise technical documents, including requirement specification documents, traceability matrices, protocols, and procedures.
- Collaboration: Work closely with cross-functional teams, including R&D, Quality, Production, and Regulatory Affairs, to ensure all documentation meets internal and external requirements.
- Compliance: Ensure all documentation and labeling comply with relevant regulatory standards and guidelines.
Requirements
- Education: Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
- Experience: 4+ years experience in R&D project management - A must!
- Previous experience in medical device project management - An advantage!
- Project Management: Strong project management skills with the ability to manage timelines, resources, and deliverables.
- Technical Skills:
- Familiarity with Engineering Change Orders (ECO) processes.
- Knowledge of Failure Mode Effect Analysis (FMEA) methodologies.
- Experience with technical writing and documentation management.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and documentation tools.
- Soft Skills:
- Ability to work independently and as part of a cross-functional team.
- Strong analytical and problem-solving abilities.
- Excellent attention to detail and organizational skills.
- Strong written and verbal communication skills in English.
- Regulatory Knowledge: Understanding of industry standards and regulatory requirements (e.g., ISO 13485, FDA, IEC) is an advantage.
- Availability: Full-time availability with the ability to take on various tasks within a fast-paced, growing environment.