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Product Development Engineer

Job description:
The Mechanical Design Engineer will be responsible for design for the mechanical and disposable medical device systems. Provide medical device compliance knowledge, design expertise, technical competency, while contributing to a team designing and developing innovative mechanical and electro-mechanical medical devices or subsystems in a design/development and manufacturing environment. Work on cutting edge medical device products to design and implement innovative and cost-effective product solutions of complex scope in order to support the organization from early prototype development through full-scale production or anywhere in between.

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Responsibilities:
  • Work on the mechanical design of new diagnostic and treatment products including documentation, materialization, and regulatory requirements.
  • Conceptualize, design, and develop mechanical components and sub-assemblies that interface with electrical/pneumatic systems.
  • Configuration product designs and systems layouts using Solidworks 3D modelling software.
  • Perform mechanical engineering analyses
  • Perform comprehensive component and system level tolerance analyses.
  • Develop test and inspection methods for evaluating components and sub-systems.
  • Support design control activities including preparation of Design Input Requirement, design-process-user FMEA’s, and design verification and validation documents.
  • Identify and define critical attributes of mechanical components to inform required component inspections or in-process testing.
  • Prepare technical documentation including presentations, engineering analysis reports, and technical work instructions.
  • Design control efforts as required by regulating bodies for the development and commercialization of Class I and Class II medical devices.
  • Provide technical support to customer service, quality regulatory teams including root cause investigations of product failures or non-conformances.

Requirements/Qualifications:
  • Bachelor’s degree in Mechanical or Biomedical Engineering (MS or PhD a plus)
  • Proficiency with Solidworks design software
  • Programming Experience using programming languages (C++, Java, Python) would be welcome
  • Demonstrated ability to prototype and keep QMS records
  • Minimum 3 years’ experience in a professional working capacity. 1-2 years’ experience with MS or PhD
  • Experience with medical regulatory / medical field
  • Experience with electro-mechanical/pneumatical system design and controls systems a plus
  • Familiarity with ISO 13485 and 510k regulatory approval process a plus
  • Fluent in English (verbal and written)
  • Good social skills, able to work in a team as well as independent
  • Excellent teamwork skills
  • Technical analytical skills, with the ability to work as an independent professional
  • Good knowledge of MS Office, Windows OS


​If you are ready to join a successful and passionate team, please apply to info@soteria-medical.com or Soteria Medical B.V., Meander 251, 6825 MC Arhem.
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Soteria Medical BV
Meander 251 | 6825 MC Arnhem 
+31  (0)26 
3763426