Mechanical Engineer Lead Developer
is a medical technology company using graphene to develop the next generation of neuro-electronic therapies targeting disorders affecting the central nervous system.
Our implant systems team is looking for a senior, hands-on mechanical engineer for implantable lead design and integration. This is a unique role perfect for someone who is interested in owning advanced projects, and being an integral member of a small, fast-moving team. You will have the opportunity to do all phases of the project as well as working closely with some of the most brilliant medical experts, and fabrication experts for system integration.
1) Design and implement mechanical design for:
1.1 implantable Leads (electrode arrays) based on graphene for application in CNS and PNS;
1.2 connectors, connecting implantable Leads to a pulse generator ('electronics box');
2) Define requirements and designs for the mechanical components for neuro active implantable medical devices;
3) Deliver detailed documentation of the device design (BOM, drawings, …) compliant with design control requirements;
4) Define test plans to verify safety and mechanical performance of the device, in compliance with applicable standards (e.g. EN45502) and in collaboration with the regulatory team;
5) Design and build experimental setups necessary to perform bench tests, characterization testing, integration, system testing;
6) Interface with EE and SW development team members to ensure mechanical design is compatible with electronics, data transmission and signal processing requirements;
7) Work with clinicians to capture, evolve and implement requirements and design suitable for a patient/clinician setting, including the design of implantation tools;
8) Identify sub-contractors who can be used to provide mechanical development and prototype build services to INBRAIN, and manage projects assigned to such 3rd parties;
9) Generate intellectual property.
1) BS or MS in Mechanical Engineering with at least 5 years of work experience in a relevant industrial setting (regulated environment, MedTech is a strong plus);
2) Detailed understanding of implantable medical device development;
3) Demonstrated skills in the areas required to perform this job: o Mechanical design using CAD o Selection of medical-grade materials and components o Safety and performance testing;
4) Strong documentation skills to comply with standards and guidelines of the medical device industry;
5) Ability to manage projects mandated to external sub-contractor;
6) Strong hands-on skills, experience with machine shop tools;
7) Demonstrated, hands-on experience with products that are transferred to production;
8) Good autonomy and initiative level;
9) Fast learner, a high energy, self-motivated and pro-active individual able to work in the fast moving environment of a dynamic start-up company;
10) Logical, creative and innovative thinker;
11) A system-thinking attitude identify areas of potential improvement and develop plans to address these; 12) Team oriented, a sparring partner to colleagues in other disciplines like electronics or clinical;
13) Results Focused;
14) Good communication and presentation skills;
15) Fluency in English required.
1) Solid experience in neuroscience with a strong interest in gaining a further understanding of this field;
2) Fully acquainted in a working environment in a tightly regulated industry (e.g. medical devices);
3) Solid understanding of Medical Risk Analysis (e.g. xFMEA);
4) Other languages (Spanish, Dutch, German, French) would be appreciated.
WHAT WE OFFER
1) An opportunity to revolutionize neurostimulation and work with some of the smartest and most talented experts from different fields;
2) Growth potential. We rapidly advance team members who have an outsized impact;
3) A fun but balanced organization with flexible work & vacation policy;
4) A potential stock option plan.
If your profile fits with the job description,
please send us your CV at email@example.com
with "Mechanical Engineer Lead Developer cv" as email subject
Become our Mechanical Engineer Lead Developer!