IVD Technical Product Manager

Mira is a San Francisco-based hormonal health company providing integrative care and hormonal testing for over 200,000 customers. In 2023, we were recognized by Inc. 5000 as America's fastest-growing femtech company. We started our company to help women and individuals reach their parenthood dreams and make their fertility journey smoother.

Mira’s most important breakthrough was inventing the market's only FDA-compliant at-home fertility monitor with quantitative technology. Since the beginning, they have been on a mission to develop data-driven hormonal health solutions to help women make confident health decisions during every stage of their lives—from the menstrual stage to menopause. Mira offers solutions to test, boost, and navigate fertility—starting from comprehensive hormone testing and supplements to fertility coaching and online courses.

We are committed to helping our customers achieve the highest possible success rates and outcomes; that is why our focus is on personalized care, the use of the most cutting-edge technology, and science-backed data.

About the position

We are seeking a Technical Product Manager to drive the development of cutting-edge in vitro diagnostic (IVD) products from concept to commercialization in our fast-paced, mission-driven startup. This role blends scientific expertise, regulatory savvy, and strategic leadership to shape the future of women’s hormonal health. You’ll lead a technical team, oversee FDA-compliant product development, and collaborate with cross-functional and international stakeholders to bring innovative solutions to life.

If you’re ready to challenge yourself at a high-growth femtech leader and make a tangible impact on women’s wellness, join us!

Key Responsibilities:

• Regulatory Compliance & Documentation: Revise and prepare FDA documentation, ensuring technical compliance with applicable regulations and standards. Contribute to the development of dossiers for regulatory submissions.
• Product Strategy & Collaboration: Partner with the Product team to define and refine product strategies that align with customer needs and company objectives. Collaborate with internal stakeholders to shape the technical roadmap.
• Design Control Leadership: Lead the design control process, overseeing the planning, execution, and documentation of product development activities to ensure robust and compliant IVD solutions.
• Team Building & Management: Build and lead a technical team, working closely with the Director of Regulatory to establish a lab for product testing and validation. Set objectives, organize activities, and provide technical guidance to team members.
• Cross-teams Communication: Act as the primary liaison with QTI to provide updates on Careomedic developments (beyond R&D scope), ensuring seamless information flow across departments. Interface with quality teams, senior leadership, and external partners to facilitate program discussions and resolve challenges.
• Technical Innovation: Guide the development and improvement of IVD products by designing experiments, interpreting data, and presenting actionable insights. Drive technological advancements that enhance the company’s portfolio.
• Resource Management: Plan and prioritize resources (human, budget, technical) for technical development and laboratory maintenance activities, ensuring efficient and effective operations.
• Stakeholder Engagement: Communicate complex technical concepts effectively through exceptional documentation and presentations, fostering alignment across organizational levels, including executive sponsors and senior leadership.

Requirements

• Bachelor’s degree in Biomedical Engineering, Life Sciences, or a related field (Master’s or PhD preferred).
• 5+ years of experience in the IVD or medical device industry, with a focus on hands-on product development and regulatory compliance.
• Proven track record in leading technical teams and managing design control processes while remaining actively involved in execution.
• Experience with FDA submissions and familiarity with global regulatory standards.
• Strong project management and organizational skills, with the ability to prioritize and manage multiple initiatives.
• Exceptional technical documentation and communication skills, with the ability to engage diverse stakeholders.
• Hands-on expertise in experimental design, data analysis, and product testing within a lab environment.
• Leadership and team-building capabilities, with experience in managing cross-functional and international teams.

Details

The role is a remote position, with a 40-hour workweek, flexible working hours and occasional overlap with the US team.

What we offer

• You will work with a dedicated, highly-engaged, international team of professionals who are passionate about helping couples and individuals start their families.
• We have a fast-paced and collaborative work environment where we encourage open communication, ownership, and independence.
• In addition to a competitive salary, we offer a performance-based bonus system based on OKR.
• We provide professional development opportunities - training courses, workshops, and seminars.

Recruiting process

Step 1: Screening call with HR - Step 2: Assessment task - Step 3: Interview with R&D Director, CTO, Director of Regulatory Affairs and Quality - Step 4: Final interview with CEO and Head of Product.