Biomedical Systems Engineer

hace 3 semanas

Barcelona, España Neuroelectrics A tiempo completo

**Who we are**:
Neuroelectrics is a creative, high-tech company offering the best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation. By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients.
We are looking for new members of our team who already live by our shared values and are inspired by our company's **Vision**. Accelerate the evolution of brain science and technology by delivering advanced solutions to help end patients suffering from brain pathologies; and our** Mission**. Revolutionize the understanding of the brain through new personalized neuromodulation therapies, anywhere and at any time.

**Position Summary**:
Reporting to the Hardware Manager, we are looking for an Industrial engineer, biomedical engineer, or similar to participate in developing and supporting EEG and transcranial electrical stimulation systems. Ideally, with broad general engineering knowledge in electronics, mechanical design, test, documentation, manufacturing, and verification/validation, according to quality system procedures. Experience working within a quality management system (ISO 13485) in the medical device industry or similar required.

**What will you do**:

- Ownership of product design history file documentation (system architecture, requirements/specs, risk management, V&V, etc.).
- Participate in system architecture definition and the translation of high-level market requirements to engineering specifications that are verifiable.
- Define and execute verification and validation test plans, root cause analyses/CAPAs, usability studies, etc.
- Contribute to maintaining on-market products by supporting engineering activities involving obsolescence, new supplier validation, and continuous improvement of specifications.
- Support regulatory submissions by creating and maintaining the required records of the product development process according to our quality management system.

**What do you need**:

- University degree in Industrial, Systems, or Biomedical Engineering.
- Must have at least 1+ year of experience in the design and development within a regulated industry (Medical devices, pharmaceuticals, automotive, or aerospace), demonstrating practical skills and technical knowledge in this specialized field.
- Knowledge in Design for Manufacturing (DFM), demonstrating an understanding of manufacturing processes and techniques.
- Familiarity with Quality Management Systems, Product Lifecycle Management, and Engineering Change Control, ensuring compliance and efficiency in product development.
- Knowledge of high-reliability production processes for electronic and mechanical assemblies.
- Knowledge of reliability and robustness test methods.
- Familiarity with common test instrumentation (oscilloscopes, multimeters, force gauges, etc.).
- Familiarity with FDA Design Controls regulations and EU MDD/MDR.
- Advanced English language skills in reading, writing, and speaking.

**Bonus points**:

- Basic knowledge of electrochemistry is a plus.
- MSc is preferred.

**You will be the perfect fit if you are/have**:

- Passionate about making a difference, gifted with a can-do attitude.
- Reliable, Responsible, and Respectful.
- Good communication and presentation skills.
- Ability to adapt and work effectively within a rapidly changing and growing environment
- Entrepreneurial spirit with the hunger to succeed; act with a founder’s mindset: have urgency, and grit, be adaptable to change, and push boundaries
- Team player, collaborative, innovative, get things done mind
- Show initiative in setting and meeting goals within an environment of managed change
- Ability to work under pressure, responsible for multiple vital tasks in parallel
- Commitment to quality.

**If you join us, you will enjoy**:

- Competitive salary in the sector (according to your experience/skills).
- 26 vacation days per year + 24th and 31th of December
- Fully stocked kitchen (Coffee, organic fruits, snacks, and beverages).
- Flexible Working Hours
- Hybrid work.
- Private Health insurance, including dental coverage.
- Professional development and collaborative environment.
- Unique opportunity to join our company early with excellent market traction and huge potential to grow
- Incredible office in Barcelona in Av. Tibidabo. (shower, stunning views of all of Barcelona, etc.)
- Team Building Events.
- Much more still to come.

**About us**:
Neuroelectrics is a creative, high-tech company offering the best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation. By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients.

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