Hardware Integration Engineer

You are responsible for

• Setting up, preparing, executing, and documenting hardware element and part level specifications, designs and tests, for both functional as well as non-functional aspects based on the overall hardware strategy.

  
  

• Defining and maintaining 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 basic safety and EMC).

  
  

• Contributing to the hardware test strategy, driving automated testing & hardware test.

  
  

• Supporting regulatory submissions activities to comply with all applicable medical standards/regulations, life cycle management, complaint investigations, and post-market surveillance activities.

To succeed in this role

You should have the following skills and experience:

• Bachelors or Master's degree in Electrical Engineering or equivalent relevant degree.

• 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.

• Experience with releasing Medica Device Products to the market, from conception to full scale production and life cycle management.

• A minimum of 15 years of experience in designing and testing electronics system elements or parts.

• 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.

• Experience using laboratory tools equipment such as oscilloscopes and soldering stations, etc. High quality standards and a drive for continuous improvement.

• Taking ownership with a pro-active mindset and eager to learn.

• Tool experience: knowledge of 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.