Mechanical Engineer with English
hace 3 semanas
A leading biomedical company is looking for someone ready to proactively bring new ideas to the team, push boundaries, and constantly look for innovation. The company believes in shared success and diverse ways of thinking, here you’ll learn, grow, and advance in an innovative culture.
As a Mechanical Engineer you will be contributing to the design, development, and test of mechanical systems. These mechanical systems are part of a complex CNS neuromodulation implant and its peripheral equipment. This active medical device will be released in EU, requiring CE mark according to the MDR, and in the USA, requiring FDA approval.
Also you will investigate, create concepts, design, develop and test mechanical components, assemblies, and systems.
Tasks- Lead the design, assembly, prototyping, and testing of mechanical components for an implantable CNS neuromodulation system, collaborating with various teams
- Collaborate with clinicians, users, and team members to refine mechanical component design requirements and guidelines
- Use design methodologies for reliability, manufacturing, and testing, including analysis and modeling
- Generate detailed documentation for device design compliant with ISO standards
- Coordinate with external partners for outsourced mechanical component design, assembly, and testing
- Develop test plans and methodologies to ensure device safety and compliance
- Design, build, and execute experimental setups for testing purposes
- Identify potential subcontractors for mechanical development and prototype construction
- Apply DFR/DFM/DFT principles in design processes
- Collaborate with cross-functional teams in product development procedures and reviews
- BS or MS in Mechanical Engineering
- +5 years of work experience in a relevant industrial setting (regulated environment, MedTech is a strong plus) with proven experience executing a full development cycle
- Experience in developing multidisciplinary medical devices is a plus
- Demonstrated skills in the areas required to perform this job: Mechanical CAD design, selection of medical-grade materials and components, safety and performance testing, requirements based Design, etc.
- Ability to manage projects mandated to external sub-contractors and manufacturing
- Strong hands-on skills, and experience with workshop tools
- Desirable machining knowledge
- Fast learner, self-motivated and pro-active individual able to work in the fast-moving environment of a dynamic start-up company
- Preferred to have solid experience in neuroscience with a strong interest in gaining a further understanding of this field
- Preferred to have solid experience in (MDR) Medical Device Regulation, ISO 13485 Quality environments, ISO 14971 Risk Analysis and IEC 60601
- Permanent contract
- Hybrid working model
- Private Health Insurance
- 23 vacation days per year + 24th and 31st of December
- A collaborative environment with a great team where innovative ideas flourish
- Meaningful and challenging projects that have a positive impact on the industry and society as a whole
- Payflow & Flexflow
- Training bonus for professional development
- Relocation Package
Our recruitment process
- Step 1: Interview with our Recruiter to get to know you better
- Step 2: Technical Interview with the Hiring Manager
- Step 3: Interview with Head of HR
- Step 4: Coffee chat with CEO
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