Development Technician I

Job Purpose:

The Technician I supports the development and testing of medical devices and diagnostic products by performing routine laboratory tasks, preparing reagents and samples, and assisting in the execution and documentation of experiments. This role ensures an accurate and timely generation of data under the guidance of scientists and senior staff, contributing to the advancement of product development projects. The position maintains a clean, safe, and compliant laboratory environment while adhering to standard operating procedures and regulatory requirements.

Key Responsibilities:

• Assist in the design, execution, and documentation of laboratory experiments to support product development and validation.

• Prepare biological and chemical reagents, samples, and test materials following established protocols.

• Operate and maintain laboratory instruments and automated systems used in assay development and device testing.

• Perform routine testing and data collection in compliance with SOPs and regulatory standards (e.g., ISO 13485:2016 & 17025:2005).

• Support the development and optimization of diagnostic assays, including ELISA, ELISPOT, flow cytometry, PCR, and other immunoassays.

• Accurately record experimental procedures, observations, and results in laboratory notebooks and electronic systems.

• Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing to support project timelines.

• Maintain a clean, organized, and safe laboratory environment, including inventory management and equipment calibration.

• Participate in troubleshooting and root cause analysis for experimental or equipment-related issues.

• Adhere to all health and safety regulations, including proper handling of human biological materials and hazardous substances.

Working Relationships:

Internal:

• Receive guidance and support from departmental staff in executing experiments and troubleshooting technical issues.

• Collaborate with departmental staff on laboratory tasks and learn best practices for equipment use and data collection.

• Ensure adherence to SOPs, documentation standards, and compliance with quality systems.

• Support Regulatory Affairs with documentation and data collection for regulatory submissions as needed.

• Assist Manufacturing in technology transfer activities and provide support during pilot production runs.

External:

• Coordinate with equipment suppliers for maintenance, calibration, and technical support under supervision.

• Support joint development activities with collaborative partners (where applicable) by preparing materials or data under direction.

Qualifications:

Education

Honours degree (BSc; minimum) or Master’s (MSc; preferred) in relevant scientific disciplines such as Immunology, Biomedical Science, Molecular Biology, Biochemistry, Biotechnology, or a related field.

Experience:

• 0–2 years of laboratory experience in a clinical, biotech, or medical device setting, ideally with exposure to immunological assays or diagnostic product development.
• Internship or co-op experience in the medical device or life sciences industry is advantageous.

Technical Skills:

• Basic understanding of ELISA, ELISPOT, flow cytometry, or molecular platforms.

• Familiarity with laboratory equipment used in ELISA, ELISPOT, flow cytometry, or molecular platforms.

• Ability to understand and follow SOPs and work instructions.

• Experience with using laboratory notebooks, and electronic laboratory notebooks (ELNs), data collection, and documentation practices.

• Proficiency in Microsoft Office (Excel, Word, Outlook); experience with data entry systems or lab management software is advantageous.

Regulatory & Quality Knowledge:

• Awareness of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

• Understanding of ISO 13485 and FDA 21 CFR Part 820 compliance requirements (preferred but not required).

Soft Skills:

• Strong attention to detail and accuracy.

• Good communication and interpersonal skills.

• Ability to work independently and as part of a cross-functional team.

• Willingness to learn and follow standard operating procedures (SOPs).

What we offer:

• Purposeful work environment

• Dynamic culture in which customers are at the forefront 

• Being part of a highly qualified team that is committed to excellence  

• Access to cutting-edge expertise through which you can make positive impact in the world around us­­

• Extensive benefits including access to private healthcare, life insurance, company pension and more.