Mechanical Engineer

Job description

### About Eko Health Eko builds AI and digital tools to enable every healthcare provider to more accurately detect heart and lung disease – the leading causes of death globally. Our FDA cleared, industry leading products are used by hundreds of thousands of clinicians on millions of patients around the world. With Eko, clinicians can detect cardiac and pulmonary disease with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible. We have strong venture capital backing from investors like Artis Ventures, Questa Capital, Highland Capital, and Mayo Clinic Ventures. Recognized by TIME magazine in 2025 as one of the world’s top healthcare technology companies, Eko is one of the fastest growing digital health companies with products used around the world at some of the most prestigious health systems. We have more than 8 FDA clearances including novel AI algorithms, and we invest heavily in quality clinical research and R&D to build and validate exceptional products for patients we care deeply about. We’ve built a mission driven, high performing, talented, and diverse team of engineers, physicians, PhD’s, creatives, and technologists. We are committed to investing in each other and our mission to ensure all patients have access to high quality care. We are headquartered in Emeryville, California and privately-held with world class investors and partners. ## **Role Summary** As the Mechanical Engineer based in China, you will serve as Eko’s lead technical expert within our supplier base. Regularly working at supplier sites, you will take ownership of executing process validations, qualifying components, and facilitating DFM collaboration during both New Product Introduction and ongoing mass production phases. This hands-on engineering role goes beyond coordination; you will actively lead validation efforts, perform detailed process audits, and manage technical documentation. By working directly with supplier quality and engineering teams, you will ensure that Company design intent is accurately realized on the production floor while providing critical feedback back to the main office. To succeed, you must possess a deep foundation in mechanical engineering with experience in manufacturing, a functional understanding of regulated environments like ISO 13485 or FDA 21 CFR Part 820, and the necessary cultural and linguistic skills to serve as a high-level technical representative with our Chinese manufacturing partners. ## **Essential Functions** - Managing and driving to closure process validations during NPI and mass production - Identifying and implementing process optimization at contract and component manufacturers - Managing component qualification during NPI and mass production - Working with component manufacturers on new processes and verifying effectiveness during NPI - Managing product labeling and document control with manufacturers - Working directly with component manufacturers on DFM feedback - Optimization of SKU management with internal stakeholders and contract manufacturer **Note:** Job duties may change at any time with or without notice. ## **Required Qualifications** - B.S. in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Materials Science, or closely related technical discipline - 5+ years of manufacturing or process engineering experience in a regulated medical device or life sciences environment - Demonstrated hands-on experience planning and executing process validation (IQ/OQ/PQ) with FDA 21 CFR Part 820 / ISO 13485 and other relevant regulatory standards for medical devices. - Experience conducting supplier audits and managing supplier quality issues through to verified closure - Proficiency reading and interpreting engineering drawings — GD&T, tolerancing, material and surface finish specifications - Experience with pFMEA, control plans, and statistical process control (SPC / Cpk / Ppk) - Demonstrated ability to author clear, compliant controlled documents (validation protocols and reports, work instructions) - Prior experience working closely with Chinese contract manufacturers - Experience supporting 510(k) submissions — manufacturing section, process validation summaries - Familiarity with PLM or QMS platforms - Proficient with Solidworks or similar CAD platform with a willingness to learn Solidworks ## **Language Requirements:** - Native or near-native Mandarin Chinese - Professional-level written and spoken English - Ability to translate nuanced technical and regulatory concepts accurately between languages ## **Travel Requirements:** - This role requires regular travel across supplier sites in Shenzhen/Guangdong and Suzhou. Estimated 30% of working time will be spent at supplier facilities. - Travel to contract manufacturers sites in Thailand and Malaysia will be required estimate 20% - Base location in Shenzhen/Guangdong is preferred based on supplier concentration ### Why join Eko Health? **We believe the ability to listen is the ability to care. Eko was named one of the World’s Top HealthTech Companies of 2025 by TIME and Statista. This honor reflects the mission to transform cardiac and pulmonary care through AI-powered stethoscopes and digital health solutions.** [Case Studies & Customer Stories](https://www.ekohealth.com/blogs/customer-stories) [Eko Blog](https://www.ekohealth.com/blogs/eko-blog) [Newsroom](https://www.ekohealth.com/blogs/newsroom) ### Work Experience & Location Requirements - This role is a remote position with expected travel. See above for more details on travel expectations. - Prolonged periods of sitting and working at a computer - Must be able to perform job duties with or without reasonable accommodation