About Mira
Mira is a San Francisco-based hormonal health company providing integrative care and hormonal testing for over 200,000 customers. In 2023, they were recognized by Inc. 5000 as America&aposs fastest-growing femtech company. We started our company to help women and individuals reach their parenthood dreams and make their fertility journey smoother.
Miras most important breakthrough was inventing the market&aposs 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 livesfrom the menstrual stage to menopause. Mira offers solutions to test, boost, and navigate fertilitystarting 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 Director to lead the development of our current and next-generation devices. The ideal candidate will have experience in developing
IVD devices and in managing multidisciplinary teams across
optics, electronics, mechanics, and firmware.
If youre excited to challenge yourself in a high-growth startup and make a real impact in womens health, wed love to hear from you!
Responsibilities
- Product Development Management Own the roadmap, stage-gates, timelines, and budgets; define milestones (concept to launch), track KPIs, allocate resources, and lead reviews with executives.
- System Ownership Architect the full device system (optics, electronics, mechanics, firmware), translate marketing/clinical needs into traceable technical specifications, and build phased roadmaps.
- Technical Leadership Lead a cross-functional team across optics, electronics, mechanics, and software; enforce best-practice workflows (Agile + ISO 13485), structured design/code/risk reviews, and ensure subsystem excellence in optics/detection, electronics/embedded, and mechanical integration.
- Verification, Validation & Risk Management Drive V&V across performance, EMC, safety, usability, and clinical correlation; lead hazard analysis, FMEA, and compliance with ISO 14971, IEC 61010, FDA/CE standards.
- Regulatory & Quality Interface Own DHF/TF documentation, design inputs/outputs, test protocols, and submissions for 510(k), CE, and TGA; respond to regulatory queries.
- Suppliers, Manufacturing & Sustaining Manage vendors for optics, PCBA, plastics, and consumables; qualify materials; transfer designs to mass production; create test/calibration fixtures; and lead root-cause analysis for field issues.
- Strategic & Cultural Leadership Scout new technologies (fluorescence, detectors, ASICs, microfluidics, digital health), mentor engineers, and foster a culture of innovation, ownership, and data-driven decision-making.
Requirements
- M.S. or Ph.D. in Biomedical Engineering, Electrical / Electronics Engineering, Optical Engineering, Physics, Mechanical Engineering, or related discipline.
- 8 + years full-cycle product development in FDA-regulated or CE-marked medical/IVD devices
- 4+ years in a lead or manager role driving multidisciplinary teams (optics, electronics, mechanics, firmware, assay).
- Expertise in optical system design (excitation/emission paths, detectors, calibration), low-noise electronics (analog front end, A/D, BLE/Wi-Fi, EMC, IEC compliance), embedded software (RTOS/bare-metal C/C++, secure BLE, IEC 62304), mechanical design (DFM/DFA, opto-mechanical alignment, usability), system engineering (requirements, risk management ISO 14971, FMEA), and data/algorithms (signal processing, calibration, prototyping in Python/MATLAB)
- Deep familiarity with FDA 21 CFR 820, 510(k) compilation, ISO 13485, ISO 14971, IEC 62366, IVDR (EU) and relevant CLSI guidelines (EP5, EP17, etc.).
- Excellent project management skills - Builds and maintains product development roadmaps, stage-gate plans, KPIs, and risk registers; fluent with Agile/Scrum boards (Jira) and waterfall artefacts (MS Project, Gantt).
- Proven track record taking at least one home-use or POC instrument from concept through launch and mass production.
- Strategic thinking balanced with hands-on pragmatism; data-driven decision making.
- Excellent verbal & written communication in English and Mandarin.
Details
The role is a on-site (Hangzhou, China), occasional overlap with US team.
What We Offer
- You will work with a dedicated, highly-engaged, international team of professionals across US and China team 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 competitive salary we offer performance-based bonus system based on OKRs.
Recruiting process
Step 1 Screening call with HR -
Step 2 Assessment task -
Step 3 Interview with CTO and R&D and Manufacturing team -
Step 4 Interview with Product and Quality team -
Step 5 -Final interview with CEO, CTO, and key Departments Heads
