Mechanical Engineer

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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:
17. Provide support to the Quality and After Sales Service teams in resolving mechanical incidents.
18. Participate in investigating non-conformities and defining 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 a multidisciplinary team, with good communication skills and a focus on continuous improvement.
• English B2/C1 proficiency for collaboration with international teams is desirable.
• Previous experience in the medical sector would be an asset.
• The salary range for this position will depend on the candidate's suitability for the profile.

What do we offer?

Participate in a research project focused on women’s health within a highly motivating team. Opportunity for professional and personal growth, as well as applying your knowledge alongside colleagues from the same field.

Workplace:

Occasional trips to visit suppliers.

Application Process:

If interested, please send us your application.