Product Developer

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Join our innovative team in IVDR product development and embark on a journey where your expertise can shape the future of diagnostics. We seek passionate product developers with a strong Life Science background and at least 5 years of experience in IVDR development in a commercial setting. Your ultimate goal will be to enhance patient care through groundbreaking solutions in the medical in vitro diagnostics field.

If you’re ready to make a meaningful impact, we invite you to apply!

Job Summary:

The Product Developer – IVD will play a critical role in designing, developing, and optimizing innovative in vitro diagnostic solutions. This involves collaboration with R&D, regulatory affairs, manufacturing, and marketing teams to ensure products meet industry standards and market needs.

Your role

• Initiate, set up, coordinate, and lead product development projects.
• Manage the entire design & development process from idea to commercial production, following ISO 13485 SOPs.
• Work with regulatory teams to ensure compliance with FDA, ISO 13485, and other standards.
• Prepare project proposals including timelines, teams, and business cases in consultation with stakeholders.
• Organize progress meetings, ensure documentation, and hold team members accountable.
• Establish testing protocols for new or improved products based on user requirements.
• Conduct feasibility studies, prototyping, verification, and validation testing.
• Monitor project deliverables, deadlines, and escalate issues as necessary.

Your profile

• PhD or MSc in Medical Biology, Immunology, Biochemistry, or a related field.
• Experience in project management within the IVD product development lifecycle.
• Knowledge of quality and regulatory standards (ISO, CLSI, FDA, IVDR).
• Experience with IVDR/FDA dossier documentation.
• Collaborative mindset, working closely with Regulatory, Production, and QA teams.
• Experience with design control, study planning, and reporting.
• Industry experience in assay or product development.
• Strong communication, writing, and analytical skills.
• Proven track record in immunology techniques and product innovation.
• Knowledge of statistical methods for analytical studies is a plus.

About Essange Reagents

Essange Reagents, spun off from Sanquin, develops and markets reagents and kits globally. The team includes over a hundred employees, with about 20 in Product Development.

What we offer

• A challenging role in a small, ambitious team.
• Salary between €3.713 and €5.402 gross/month, depending on experience.
• Flexible working hours, 8.33% year-end bonus, and at least 201 vacation hours annually.
• Customizable employment terms, training opportunities, travel and home office allowances.
• Temporary position with potential for permanence.

More info

Contact Henk te Velthuis or Marcel Jacobs for more information. Submit your CV and motivation letter via the application button. Pre-employment screening applies.