Production Engineer

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 Production Engineer plays a critical role in the efficient functioning of mechanical systems, equipment, and production machinery within a medical device manufacturing facility. Reporting to the Production Manager - Operations, this position bridges the technical and production departments by supporting associates with machine setup, maintenance, troubleshooting, and continuous improvement. The Production Engineer is responsible for developing and executing maintenance plans, conducting repairs, performing calibration and validation procedures, managing spare parts inventory, and ensuring compliance with safety protocols and regulatory standards. With a focus on minimizing downtime and optimizing production efficiency, the Production Engineer collaborates cross-functionally to troubleshoot issues, implement corrective actions, and support continuous improvement initiatives.

Primary Duties and Responsibilities:

• Assisting and executing maintenance plans for mechanical systems and equipment used in IVD manufacturing, including machinery used in both packing and operations functions. This includes scheduling routine inspections, preventive maintenance tasks, and repairs to minimize downtime and ensure uninterrupted production.
• Quickly diagnosing mechanical issues with manufacturing equipment and taking corrective action.
• Conducting repairs and adjustments to restore functionality and maintain production efficiency across both packing and operations lines.
• Collaborating with production associates on machine setup, calibration, troubleshooting, and identify machine-related issues, providing hands-on technical assistance, and ensure smooth workflow.
• Performing calibration and validation procedures on mechanical equipment to ensure compliance.
• Maintaining calibration records and documentation for auditing purposes.
• Maintaining an inventory of equipment list and critical spare parts used in IVD manufacturing areas.
• Coordinating with suppliers to ensure timely availability of parts to minimize downtime.
• Conducting risk assessments and implementing safety measures to ensure worker safety.
• Maintaining comprehensive documentation of maintenance activities, equipment logs, and repair records for all production machinery.
• Generating reports on equipment performance, maintenance metrics, and downtime analysis to track reliability and identify areas for improvement.
• Staying abreast of advancements in mechanical engineering, automation technologies, and IVD manufacturing processes.
• Identifying opportunities for process optimization, efficiency gains, and cost savings through equipment upgrades or workflow improvements in both packing and operations.
• Collaborating with the other departments to troubleshoot equipment issues, implement corrective actions, and support production goals.
• Participating in new equipment installations or process validations.
• Responding promptly to equipment breakdowns or emergencies to minimize production disruptions.
• Implementing contingency plans and troubleshooting procedures to restore normal operations.
• Other facility repair duties as assigned.
• Work under

ISO 13485

2016 (Medical device - Quality management systems) standards where applicable.

Knowledge/Skills/Abilities:

• Bachelor of Science in Engineering, preferably in mechanical engineering.
• 1-3 years of related work experience in GMP/Bio-Pharma maintenance/engineering.
• Demonstrated abilities in mechanical and electrical repairs and maintenance of production machinery.
• Strong technical writing skills to effectively communicate technical concepts.
• Ability to work before deadlines, with strong planning, organizational, and prioritization skills in a fast-paced production environment.
• Effective interpersonal and communication skills with the ability to work collaboratively with cross-functional production teams.
• Proficiency in both English and Chinese (Mandarin) is preferred.

Pay:

$68,000.00 - $83,000.00 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 Retirement plan Vision insurance

Experience:

Manufacturing:

2 years (Preferred)

Work Location:

In person