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Product Development Manager
vor 1 Woche
Company Overview
The Biopôle is a leading center for biomedical innovation, dedicated to transforming scientific discoveries into life-changing medical solutions. Our mission is to create cutting-edge products that improve patient outcomes and quality of life.
Job Description
We are seeking an experienced R&D Engineer to join our team as a Product Development Manager. In this role, you will be responsible for leading the design and development of innovative medical devices, from concept to market launch. You will work closely with cross-functional teams to ensure seamless execution of product development projects.
Key Responsibilities:
- Lead design and development of medical devices, including TRIFLO Heart Valve prosthesis and surgical accessories.
- Collaborate with industrial partners to support industrialization efforts.
- Develop and maintain design control and risk management documentation.
- Create and update product assembly and detailed drawings using CAD software.
- Lead process validation activities to ensure regulatory compliance.
- Develop test methods and tooling.
- Support Engineering Change Requests and document design documentation updates.
Required Skills and Qualifications
To succeed in this role, you must have:
- Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field.
- Minimum 4 years' experience as an engineer in the medical devices sector, preferably in cardiovascular industry.
- Technical knowledge in mechanics, surface treatment, and material science.
- CAD proficiency, specifically in SolidWorks software.
- Proven experience with product development and regulatory submission.
- Knowledge of medical device industry regulations (FDA, MDR, ISO 13485, and ISO 14971).
Benefits
We offer a dynamic and collaborative work environment, competitive salary, and opportunities for professional growth and development. If you are passionate about biomedical innovation and want to make a meaningful impact, apply now
