Mechanical Engineer with English

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 youll 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 crossfunctional teams in product development procedures and reviews

Requirements

• 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 medicalgrade materials and components safety and performance testing requirements based Design etc.
• Ability to manage projects mandated to external subcontractors and manufacturing
• Strong handson skills and experience with workshop tools
• Desirable machining knowledge
• Fast learner selfmotivated and proactive individual able to work in the fastmoving environment of a dynamic startup 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

Benefits

• Permanent contract
• Hybrid working model
• Private Health Insurance
• 23 vacation days per year 24th and 31st of December
• Acollaborative 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