Nederland

R&D Engineer, Leiden

R&D Engineer, Leiden
Advertentietekst
Rapidemic is seeking a Junior R&D Engineer to join our Engineering team and contribute to the development of next-generation in vitro diagnostic (IVD) devices. As an R&D Engineer you will support the design, prototyping, characterization, and verification of integrated diagnostic systems spanning fluidics, thermal management, optics, electronics, and consumable components. Job Title: R&D Biomedical Engineer | Level: Junior | Reports to: Head of Engineering | Type: Full-time (40h/week) | Location: BioPartner 3, Leiden Bioscience Park, Zuid-Holland | Modality: On-site (1 day/week remote possible) | Contract: Temporary, 1 year with possible extension | Start Date: As soon as possible (latest August 2026)Responsibilities

Support the design and prototyping of IVD device subsystems and consumables, including mechanical, fluidic, thermal, and electromechanical components. Build, assemble, and iterate on engineering prototypes in the lab; perform hands‑on testing using standard and custom lab equipment. Plan and execute design verification experiments, including writing test protocols, collecting and analyzing data, and producing clear technical reports.Generate and maintain CAD models, engineering drawings, and technical documentation in line with internal design control procedures. Support failure analysis, root‑cause investigation, and design iterations based on experimental and field feedback. Work cross‑functionally with other teams to integrate subsystems into products.Maintain accurate records in the design history file (DHF) and contribute to risk management activities (ISO 14971) under the guidance of senior engineers. Help maintain a safe, organized, and productive lab environment. Participate in project meetings, contribute ideas, and present findings. Education

B.S. or M.S. degree in Mechanical, Biomedical, Chemical Engineering, Applied Physics, or closely related disciplines. 0–2 years of relevant experience (internship, thesis project, or student team work); recent graduates are welcome. Required Skills

Solid foundation in engineering fundamentals: mechanics, heat transfer, fluid dynamics, or basic electronics. Hands‑on prototyping skills: experience with at least one CAD software (SolidWorks, Fusion 360, or equivalent), 3D printing, basic machining, soldering, or breadboarding. Comfortable with experimental work, defining test setups, executing measurements, and interpreting data.Strong data analysis skills using scientific tools (Python, MATLAB, or equivalent) and standard office tools. Strong written and verbal communication in English; ability to produce clear, structured technical documentation. Curious, methodical, and self‑driven; able to work independently on well‑scoped tasks while collaborating effectively in a small team.Attention to detail and a proactive attitude. Preferred Skills

Experience with medical device development, IVDs, or other regulated environments (ISO 13485, IEC 62366, IEC 61010, IEC 60601, or IVDR/FDA frameworks). Familiarity with design controls, risk management (ISO 14971), and verification&validation methodology. Experience with microfluidics, low‑volume liquid handling, thermal control systems, or embedded electronics. Knowledge of statistics for engineering (DOE, GR&R, capability analysis); coursework or certification (Six Sigma Green Belt) is a plus. Familiarity with molecular biology workflows at a conceptual level; sufficient to communicate effectively with assay team members. Experience with version‑controlled documentation, PLM systems, or electronic QMS tools.Awareness/exposure to design for manufacturing (DFM) and design for assembly (DFA) principles. Benefits

A competitive salary. An incredible learning experience working in a growing start‑up. A relaxed work atmosphere. The opportunity to explore and test your own ideas. A working experience in a European hub for life sciences innovation. A work experience in the diagnostics industry.

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