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.

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.