Key Skills

Job Description

Business Unit: IntraSight Hardware Contract Type: Contingent Via Randstad (high possibility of extension/conversion) Location: Best, Netherlands (Hybrid: 3–4 days on-site) In the Mechanical Engineer role you will be a part of the multidisciplinary IntraSight Hardware Team and you will bring innovative 2D and 3D imaging clinical solutions to our customers around the world. We help physicians to decide, guide, treat and confirm the right care in real time during a minimal invasive procedure to enable better outcomes for each patient. We touch patients’ lives when it matters most and we aim to do it in the most reliable, effective and sustainable way. Your Are Responsible For Setting up, preparing, executing, and documenting hardware element and part level specifications, designs and tests, for functional mechanical aspects based on the overall hardware strategy. You will be responsible for: Defining and maintaining mechanical requirements, design, implementation, test and integration of module/sub-system in accordance with the higher-level architectural requirements and design specifications. Producing high quality documentation with solid arguments backed by evidence. Ensuring that the design is consistent with the higher-level architecture and requirements. Reviewing product specifications, writing test protocols and acceptance criteria, and executing, and documenting element and part level tests. Determining the approach for element/part acceptance tests (including thermal analysis). Create and maintain 2D and 3D CAD models with special attention Geometric Dimensioning and Tolerancing (GD&T). Supporting regulatory submissions activities to comply with all applicable medical standards/regulations, life cycle management, complaint investigations, and post-market surveillance activities. Releasing and maintaining mechanical drawings, CAD data, parts, and associated documentation in the PLM system. Supporting components assessment and selection of mechanical and electromechanical components to assess technical fit, interfaces, documentation, and verification needs for component changes. To succeed in this role you need have the following skills and education: Bachelors or Master's degree in Mechanical Engineering or equivalent relevant degree with 7 - 10 years of experience in designing and testing mechanical system elements or parts. Experience with releasing Medical Device Products to the market, from conception to full scale production and life cycle management. Documentation & Communication: A solid track record in creating audit-proof documentation. The ability to absorb large amounts of information and compress that into understandable bite-sized clear and succinct documents for both technical and non-technical stakeholders. Quality & Standards: Prior experience in engineering quality in the context of medical device development (documentation, traceability, sourcing) and quality systems. Expert in Basic Safety 60601-1. Familiarity with EMC 60601-1-2, Quality Management 13485, and risk management standards 14971 for Medical Devices. Analysis & Lab Competencies: FEA analysis for both thermal and stress/strain. Experience using laboratory tools equipment. Tools & Software: Tool experience: knowledge of Solidworks, PLM database(s) (i.e. Windchill is a plus) and requirements/test case management tools (e.g. DNG, Doors) and proficiency in MS Office suite. Mindset: High quality standards and a drive for continuous improvement. Taking ownership with a pro-active mindset and eager to learn. If you are willing to explore it further, kindly apply before November 10, 2026. Thanks

Core Responsibilities

Define, design, integrate, test, and document mechanical modules and components in line with system requirements and architecture, including CAD models, drawings, and acceptance testing. Support regulatory submissions, lifecycle management, complaint investigations, post-market surveillance, and component assessments while maintaining mechanical data and documentation in the PLM system.

Requirements

A bachelor's or master's degree in Mechanical Engineering or an equivalent relevant degree, with 7–10 years of experience designing and testing mechanical system elements or parts, is required. Candidates should have medical-device product lifecycle experience, strong audit-ready documentation and quality-system knowledge, familiarity with relevant IEC/ISO standards, FEA and laboratory experience, and proficiency with SolidWorks and related engineering tools.