R&D Technical Lead (Lateral Flow IVD)

Mira; San Diego (CA); Remote; USD 120,000 - 160,000; Full time

Job summary

Mira, a leading hormonal health company, seeks an R&D Tech Lead to drive product development from ideation to commercialization. This remote role requires a Ph.D. and extensive experience in IVD, focusing on innovation and collaboration across international teams. Join us to make a significant impact on women's health.

Benefits

Performance-based bonus system

Professional development opportunities

Flexible working hours

Qualifications

• 8+ years of R&D experience in IVD, medical device, or biotechnology industry.
• 3+ years in a leadership role managing R&D teams or projects.
• Proven track record of bringing IVD products from concept to market.

Responsibilities

• Oversee design, development, and validation of IVD products.
• Manage multiple R&D projects, setting timelines and budgets.
• Partner with regulatory affairs to ensure compliance with international standards.

Skills

Leadership

Project Management

Collaboration

Innovation

Education

Ph.D. in Biomedical Engineering, Molecular Biology, Chemistry, or related field

Job description

About Mira

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 looking for an R&D Tech Lead to oversee all aspects of product development, from ideation to commercialization, in a fast-paced startup environment. This role requires scientific expertise, strategic leadership, and a strong ability to bridge cultural dynamics, particularly our international team.

If you want to challenge yourself at a high-growth startup and make a difference for women's health, please join us!

Responsibilities

• Product Development:
• Oversee the design, development, and validation of IVD products
• Drive end-to-end R&D processes, including feasibility studies, prototyping, and clinical validation.
• Ensure products meet performance, quality, and regulatory standards (e.g., FDA, CE-IVD, TGA, Health Canada).
• Cultural Leadership & Team Development:
• Leverage experience working with teams in China to foster collaboration and align goals across geographies, including travel to China for 2-3 months per year for on-site collaboration and training.
• Cultivate and train the R&D team on the startup’s culture of innovation, agility, and accountability.
• Instill a high level of ownership in the team, empowering individuals to take initiative and drive results.
• Project Management:
• Manage multiple R&D projects, setting timelines, budgets, and resource allocation across global teams.
• Led design control process from beginning to end.
• Mitigate risks and troubleshoot technical and cultural challenges to keep projects on track.
• Collaboration:
• Partner with regulatory affairs to ensure compliance with international standards.
• Write and review registration files.
• Work with manufacturing teams to transition products from R&D to production.
• Collaborate with commercial teams to align R&D efforts with market needs and customer feedback.
• Collaborate with clinical teams to design and execute clinical trials, ensuring data integrity and compliance with regulations.
• Innovation & IP:
• Champion the development of intellectual property (IP), including patents and trade secrets, with an understanding of global IP strategies.
• Stay ahead of industry advancements to integrate novel technologies into product pipelines.

Near-term Goals - to be added

Requirements

• Ph.D. in Biomedical Engineering, Molecular Biology, Chemistry, or a related field.
• 8+ years of R&D experience in the IVD, medical device, or biotechnology industry.
• 3+ years in a leadership role managing R&D teams or projects.
• Proven track record of bringing IVD products from concept to market.
• Familiarity with regulatory requirements.
• Deep knowledge of IVD technologies (e.g., immunoassays, molecular diagnostics, point-of-care devices).
• Proficiency in experimental design, data analysis, and validation protocols.
• Experience in a startup or fast-paced environment and building R&D 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 OKRs
• We provide professional development opportunities - training courses, workshops, and seminars

Recruiting process

Step 1 ‘Screening call with HR’ - Step 2 ‘Interview with CEO and CTO’ - Step 3 ‘Assessment task’ - Step 4 ‘Interview with the Director of Regulatory Affairs and Head of Product’