About Premium Fertility
At Premium Fertility, we are looking for a Mechanical Engineer to join our R&D Department.
Premium Fertility is an innovative biomedical company dedicated to transforming the field of assisted reproductive technology. Our mission is to improve pregnancy success rates by addressing the critical challenges in embryo transfer through our groundbreaking Transfer Direct System (TDS). This semi-automated medical device is designed to enhance embryo implantation efficiency, offering a revolutionary approach to in vitro fertilization (IVF).
Key Accountabilities and Responsibilities:
1. Mechanical design and optimization.
2. - Design and redesign key TDS components (CEC and CET equipment, consumables, etc.) to improve accuracy, robustness and ease of use.
3. - Select appropriate materials (especially plastics and polymers) and manufacturing methods (injection molding, machining, 3D printing, etc.) based on functional and cost requirements.
4. Analysis and validation
5. - Employ simulation tools (e.g. FEA) to validate structural strength and mechanical functionality.
6. - Participate in the development and execution of verification and validation plans, including durability and biocompatibility testing, where appropriate.
7. Transfer to production
8. - Define and document manufacturing and quality control processes to ensure reproducibility and scalability of designs.
9. - Collaborate with suppliers, workshops and/or industrial partners to ensure proper implementation of designs and optimization of costs and timelines.
10. Change management and documentation
11. - Ensure traceability of design changes and their impact on technical documentation (DHF, DMR, etc.).
12. - Write and maintain updated engineering and audit support documentation (ISO 13485, MDR).
13. Innovation and continuous improvement
14. - Explore new manufacturing technologies, advanced materials and design improvements that increase efficiency, quality and/or cost effectiveness.
15. - Participate in multi-disciplinary team meetings, proposing solutions that integrate electronics, software and mechanics for overall TDS operation.
16. Technical Support
* - Provide support to the Quality and After Sales Service teams in the resolution of mechanical incidents.
* - Participate in the investigation of non-conformities and in the definition of corrective and preventive actions.
Required skills and experience:
* Proficient in CAD software (e.g. SolidWorks, Inventor, CATIA or others)
* Strong knowledge of mechanical simulation, stress analysis and strength of materials (FEA)
* Experience in material selection and validation (plastics, metallic, etc.)
* Knowledge of manufacturing processes: injection molding, CNC machining, assemblies, etc.
* Ability to manage mechanical engineering suppliers and subcontractors.
* Familiarity with medical device regulations and standards (ISO 13485, MDR) is desirable.
* Ability to work in multidisciplinary team, good communication and focus on continuous improvement
* English B2/C1 for collaboration with international teams is desirable.
* Previous experience in the medical sector would be an asset.
Salary:
* The salary range for this position will depend on the suitability of the candidate for the requested profile.
* Full-time employment contract.
What do we offer?
Participate in a research project framed within women's health in a highly motivating team.
• Opportunity for professional and personal growth, as well as the application of knowledge working with colleagues from the same professional field.
Workplace:
Our facilities are in Parque Tecnológico de Paterna. Rda. de Narcís Monturiol, 11, Bloque C, 46980 Paterna, Valencia
Occasional trips to visit suppliers.
Application Process:
If you are interested, we would appreciate it if you could send us your application.