PixCell Medical is seeking a dedicated and skilled Engineer to join our dynamic Engineering team. We specialize in developing cutting-edge in vitro diagnostic (IVD) analyzers for live cell diagnostics, leveraging our proprietary, multidisciplinary technology. As an NPI & Design Control Engineer, you will play a crucial role in managing the entire product lifecycle and facilitating the transition to production. This includes ongoing product design enhancements, managing the Device Master Record (DMR), Device History File (DHF), and overseeing design records such as Engineering Change Orders (ECO), Corrective and Preventive Actions (CAPA), and Non-Conformance Reports (NCR).

Key Responsibilities:

• Oversee the complete product lifecycle, ensuring seamless transfer to production.

• Implement continuous design improvements and maintain comprehensive design records.

• Collaborate with cross-functional teams to enhance product design and production processes.

• Identify and lead initiatives for production process improvements to increase efficiency, reduce waste, and enhance product quality.

• Analyze production data and feedback to inform design modifications and optimize manufacturing workflows.

• Work closely with software, mechanical, electrical, and optical teams to ensure cohesive integration and functionality of all product components.

Desired Skills & Experience:

• Bachelor’s degree in Biomedical, Aerospace, or Mechanical Engineering from a recognized institution.

• 3-6 years of experience in transferring multidisciplinary medical products, including software, mechanical, optical, and electrical components, from development to production.

• Proven track record in implementing production process improvements and driving operational excellence.

• Proficiency in training and guiding manufacturing line teams.

• Experience with ECO, CAPA, NCR, and MRB management.

• Hands-on experience with SolidWorks and SolidWorks PDM.

• Self-motivated, resourceful, and capable of working independently.

• Strong team collaboration skills and attention to detail.

• Fluent in English and proficient with ERP Systems (Priority) and MS Office Suite.

Join us at PixCell Medical and contribute to revolutionizing diagnostics with your expertise and passion across multiple engineering disciplines.

Report to: Engineering Manager

Position scope: Full time