Founded in 2010, iHealth Labs is dedicated to empowering people to live healthier lives. The company is a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests and is at the forefront of the digital health revolution.
In 2018, iHealth launched its Unified Care program to address the issue of managing chronic diseases. Unified Care specialists support patients at home between doctor’s appointments with remote patient monitoring (RPM) and chronic care management (CCM) to achieve better health outcomes.
In November 2021, iHealth's COVID-19 Antigen Rapid Test received Emergency Use Authorization from the U.S. Food and Drug Administration for over-the-counter sales. Since then, iHealth has become a key supplier of at-home COVID tests to the federal government, state governments, nonprofits, and individual consumers.
iHealth Labs is a leader in digital health solutions, with a mission to revolutionize the healthcare industry by making quality health management accessible and affordable for all.
Position Overview
The Senior Engineer serves as a key technical and operational partner to the Production Manager, supporting daily manufacturing activities and helping ensure production targets are achieved safely, efficiently, and consistently. This role acts as a hands-on bridge between Production, Engineering, Quality, and Maintenance, providing technical leadership while supporting production planning, line performance, troubleshooting, and continuous improvement.
The Senior Engineer works closely with production associates and supervisors to support machine setup, changeovers, equipment troubleshooting, production recovery, process optimization, and training. The role also provides backup support to the Production Manager in coordinating daily production priorities, resolving operational issues, monitoring performance, and implementing improvement initiatives.
Primary Duties and Responsibilities:
- Support the Production Manager with daily production priorities, line readiness, schedules, and operational issues.
- Provide hands-on support for machine setup, startups, changeovers, troubleshooting, and production recovery.
- Diagnose mechanical, electrical, pneumatic, PLC, sensor, HMI, and automation issues to minimize downtime.
- Monitor production performance, including output, throughput, downtime, yield, scrap, OEE, and equipment reliability.
- Identify and implement improvements to productivity, equipment efficiency, cycle time, quality, and cost.
- Lead or support root-cause investigations and corrective actions for production and equipment issues.
- Work closely with Production, Quality, Engineering, and Maintenance to maintain production continuity.
- Train and provide technical guidance to production associates on equipment operation, setup, and troubleshooting.
- Support preventive maintenance, equipment qualification/validation, new equipment introduction, and revalidation with technical team.
- Maintain equipment SOPs, work instructions, maintenance records, and other controlled documentation.
- Analyze production and equipment data using Excel, Python, and/or AI-assisted tools to identify trends and improvement opportunities.
- Support compliance with ISO 13485, GMP, FDA, safety, and quality requirements.
Knowledge/Skills/Abilities:
- Bachelor of Science in Engineering — Mechanical, Electrical, Mechatronics, or Automation Engineering preferred.
- 4+ years of hands-on experience maintaining and troubleshooting automated production line equipment in a GMP / medical device manufacturing environment (IVD preferred).
- Demonstrated ability in mechanical, electrical, pneumatic, and control-system (PLC, sensors, HMI) diagnosis and repair.
- Experience supporting production operations, machine setup, changeovers, and downtime recovery.
- Strong problem-solving, root-cause analysis, communication, and organizational skills.
- Proficiency in Excel; Python, data analytics, or AI-assisted analysis is a plus.
- Knowledge of ISO 13485, GMP, FDA, and medical device manufacturing requirements.
- English and Mandarin proficiency preferred.
Pay: $68,000.00 - $95,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Relocation assistance
- Vision insurance
Application Question(s):
- Will you now or in the future require employer-sponsored work authorization (visa sponsorship) to work in the United States?
Experience:
- Manufacturing: 3 years (Preferred)
Work Location: In person
