Product Developer

Essange Reagents; Amsterdam; On-site; EUR 41,437 - 60,286; Full time

Benefits offered by this job

Flexible working hours

8.33% year-end bonus

201 vacation hours annually

Customizable employment terms

Training opportunities

Travel and home office allowances

Job summary

A leading company in the medical diagnostics field seeks a Product Developer to drive innovative IVDR solutions. The role involves managing product development projects, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. Candidates should have a strong background in Life Sciences and project management experience. This position offers a competitive salary and flexible working conditions.

Qualifications

• At least 5 years of experience in IVDR development.
• Experience in project management within the IVD product development lifecycle.

Responsibilities

• Lead product development projects from idea to commercial production.
• Ensure compliance with FDA, ISO 13485, and other standards.
• Conduct feasibility studies, prototyping, verification, and validation testing.

Skills

Project Management

Communication

Analytical Skills

Education

PhD or MSc in Medical Biology

PhD or MSc in Immunology

PhD or MSc in Biochemistry

Tools

ISO 13485

FDA Standards

Job description

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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.