Mechanical Engineer (Medical Devices)

Location: Shenzhen/Guangdong, China, with regular travel to supplier sites in Shenzhen/Guangdong and Suzhou. Travel to contract manufacturers in Thailand and Malaysia is required. The role is described as remote with expected travel, while the workplace is listed as hybrid; approximately 30% of working time will be spent at supplier facilities and an additional 20% traveling to Thailand and Malaysia.

Company

hirify.global Health develops FDA-cleared AI-powered stethoscopes and digital health tools for detecting and managing cardiac and pulmonary disease.

What you will do

• Lead process validations during new product introduction and mass production, including driving activities through verified closure.
• Qualify components and collaborate with manufacturers on new processes and process effectiveness.
• Conduct supplier audits, manage supplier quality issues, and implement manufacturing process improvements.
• Provide DFM feedback and ensure design intent is accurately implemented on the production floor.
• Manage product labeling, controlled documentation, and SKU optimization with internal stakeholders and contract manufacturers.
• Provide technical feedback from supplier sites to the main office.

Requirements

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Materials Science, or a related technical discipline.
• 5+ years of manufacturing or process engineering experience in a regulated medical device or life sciences environment.
• Hands-on experience planning and executing IQ/OQ/PQ process validation under FDA 21 CFR Part 820, ISO 13485, and other medical device regulations.
• Experience with supplier audits, supplier quality issue resolution, engineering drawings, GD&T, pFMEA, control plans, SPC, Cpk, and Ppk.
• Ability to author validation protocols and reports, work instructions, and other compliant controlled documents; familiarity with PLM or QMS platforms.
• Proficient in SolidWorks or a similar CAD platform, with willingness to learn SolidWorks. Native or near-native Mandarin Chinese and professional-level written and spoken English are required, including the ability to translate technical and regulatory concepts accurately.

Nice to have

• Experience supporting 510(k) submissions, including manufacturing sections and process validation summaries.
• Previous experience working closely with Chinese contract manufacturers.

Culture & Benefits

• Mission-driven work focused on improving cardiac and pulmonary care.
• Collaboration with engineers, physicians, PhDs, creatives, and technologists.
• Work with suppliers across China and internationally, including Thailand and Malaysia.
• Ability to perform the job with or without reasonable accommodation.