Job Title
Biomedical Engineering Expert
Company
Career Work Source Company
Location
The Netherlands (e.g. Amsterdam, Eindhoven, Utrecht, or other region depending on assignment)
Job Type
Full‑Time / Permanent / Project‑based (depending on needs)
Reports To
Head of Engineering / R&D Manager / Clinical Technology Director / Technical Lead
About Us
Career Work Source Company is a staffing and engineering consultation firm delivering high‑quality technical expertise to healthcare institutions, medical device manufacturers, research organizations, and regulatory bodies across the Netherlands. We strive to ensure safety, innovation, compliance, and superior performance in all biomedical engineering projects.
Job Summary
As a Biomedical Engineering Expert, you will be a lead technical specialist responsible for the design, development, maintenance, and oversight of biomedical equipment and systems. You will ensure that medical devices meet technical, regulatory, and safety standards, and you will work closely with cross‑functional teams (clinical, regulatory, R&D, quality) to drive innovation and reliability.
Key Responsibilities
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Lead design, prototyping, testing, and validation of medical devices, diagnostics equipment or related biomedical systems.
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Oversee preventive maintenance, calibration, repair, and lifecycle management of biomedical equipment in clinical, research, or production settings.
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Ensure compliance with Dutch and EU medical device regulations (e.g. MDR), safety standards, and quality systems (ISO 13485, IEC, etc.).
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Perform risk assessments, hazard analyses, verification & validation (V&V), and prepare technical documentation for regulatory submissions.
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Collaborate with clinicians, scientists, and other engineers to understand user needs, specify product requirements, and translate them into technical solutions.
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Troubleshoot complex device/system failures; propose improvements, design modifications or corrective actions.
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Supervise sourcing, integration, or customization of hardware, software, sensors, or materials as needed.
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Manage projects: timelines, budgets, testing protocols, quality checks, documentation.
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Support or lead training for clinical staff / end users on safe operation, maintenance, and proper usage of devices.
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Stay up to date with emerging technologies, materials, biomedical research, and regulatory changes in the EU and globally.
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Participate in innovation initiatives: R&D collaborations, patenting, product improvement programs.
Qualifications & Skills
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Master’s degree (or PhD) in Biomedical Engineering, Medical Device Engineering, Bioengineering, or a closely related field.
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Significant experience (e.g. 5+ years) in medical device design, clinical engineering, or biomedical systems—ideally including work with regulatory submissions in EU context.
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Deep knowledge of relevant standards/regulations: European Medical Device Regulation (MDR), ISO 13485, CE marking, risk management (ISO 14971), etc.
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Strong technical skills: electronics, embedded systems, software/firmware, sensors, materials/biocompatibility, mechanics. Depending on role: imaging, diagnostics, robotics etc.
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Experience with test & measurement equipment, calibration, verification/validation procedures.
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Excellent problem solving, analytical skills, attention to detail. Ability to lead root‑cause analysis etc.
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Good documentation and technical writing skills (specifications, verification reports, design history file, user manuals etc.).
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Project management skills, ability to coordinate across teams.
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Communication skills—able to interact with clinicians, regulatory bodies, suppliers, etc. Proficiency in English necessary; knowledge of Dutch is an advantage.
Working Conditions
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Mostly lab / R&D environment in company premises, medical device manufacturer, or clinical facility; some field work may be required.
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Must adhere to safety protocols; use of protective equipment when dealing with devices, chemicals etc.
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May involve occasional travel (within NL or EU) for conferences, audits, supplier visits.
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Typical work week; possible occasional overtime depending on project deadlines or regulatory submission cycles.
Compensation & Benefits
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A competitive salary aligned with Dutch market rates for senior technical/expert roles in biomedical engineering.
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Benefits as per Netherlands labour law: pension, health insurance, vacation, etc.
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Bonuses or incentives tied to project delivery, innovation, or regulatory / quality milestones.
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Opportunities for professional development: training, conferences, certification courses.
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Possible opportunities for academic / industry collaboration.