Mechanical Design Engineer
At INNERVIA Bioelectronics we're looking for a Mechanical Design Engineer to help us DECODE NERVE SIGNALS INTO MEDICAL SOLUTIONS!
ABOUT THE ROLE
INNERVIA is seeking a Mechanical design engineer to lead the design of a neuro active implantable device expertise (>5 years, mandatory) for developing implantable leads, electrodes that interact with the Peripheral Nerve System (PNS), such as the vagus nerve. In addition, mechanical engineering support for e.g., test fixtures, electronics enclosures etc. is to be provided.
1) Define requirements and designs for the mechanical components for neuro active implantable medical devices.;
2) Design and implement mechanical design for:
- implantable Leads (electrode arrays) based on graphene for application in PNS.;
- connectors, connecting implantable Leads to a pulse generator ('electronics box').;
- sterile, sales and transport packaging.;
3) Design for reliability, manufacturing, and test, including concept engineering, functional analysis, stress analysis, and mechanical modeling.;
4) Deliver detailed documentation of the device design (DRs, BOM, drawings, …) compliant with design control requirements.;
5) Define test plans to verify safety and mechanical performance of the device, in compliance with applicable standards (e.g., EN45502, ISO14708) and in collaboration with the regulatory team.;
6) Design and build experimental setups necessary to perform bench tests, characterization testing, integration, system testing.;
7) Interface with EE and SW development team members to ensure mechanical design is compatible with electronics, data transmission and signal processing requirements.;
8) Work with clinicians to capture, evolve and implement requirements and design suitable for a patient/clinician setting, including the design of implantation tools.;
9) Support in generating intellectual property (IP).
Applicants should meet the following requirements:
BSc or MSc in Mechanical Engineering with at least 5 years of work experience in developing an active implantable device and having a detailed understanding of implantable medical device development.;
Demonstrated skills in the areas required to perform this job:
1) Mechanical design using 2D/3D CAD, and FEM modelling.;
2) Selection of medical-grade materials and components.;
3) Safety and performance testing of Regulatory requirements.;
4) Strong documentation skills and experience to comply with standards and guidelines of the medical device industry, e.g., medical risk analysis /FMEA, requirement engineering, design specifications, verification planning and execution.;
5) Demonstrated, hands-on experience with products that are transferred to production.;
6) Results Focused, highly motivated, fast learner and pro-active individual able to work in the fast-moving environment of a dynamic start-up company.;
7) A system-thinking attitude identify areas of potential improvement and develop plans to address these.;
8) Team player has the ability to lead and a sparring partner to colleagues in other disciplines like electronics or clinical.;
9) Logical, creative, and innovative thinker, that wants to create an impact while having fun.;
10) Fluency in English required (company language).
Do you want to help us DECODING NERVE SIGNALS INTO MEDICAL SOLUTIONS? Then we'd love to hear about you!