In your new role, you will be a part of mechanical R&D team where you will be involved in supporting evaluation and validation of biocompatibility aspects for products related to cochlear implant systems. You will also have to work with teams from different group sites on following areas:
- Manage documentation of biological safety assessment (protocol and validation reports) in accordance with ISO 10993-1 and FDA guidance.
- Assess biological risks in relation to product and manufacturing risk analysis
- Evaluate and document the changes / evolutions (design, process,…) of product during the life cycle
- Conduct reviews of the state of the art for materials
- Define and manage the achievement of chemical and biological testing need for assessments
- Analyze normative developments, determine the impact on existing validations and draw up compliance strategies if necessary
- Technical support to other collaborators on materials, chemicals and biological aspects in R&D projects as well as manufacturing issues
- Coming from an engineer training or equivalent diploma in the biological / medical field, you have a first successful experience in the medical devices or pharmaceutical sector (internship, work-study program, 1st professional experience) with a similar position. We expect you to have competencies in the following areas:
- Knowledge of quality and regulatory requirements (Medical devices European Directives / Regulation and ISO 13485, 21 CFR part 820 would be a plus)
- Knowledge of biocompatibility (ISO 10993 series) and risk assessment
- Knowledge of implantable materials and physicochemical analysis methods
- English as well as French read, spoken and written daily
- Notions in toxicology / pharmacology would be a plus
Analysis and synthesis skills, ability to communicate with different interlocutors, strong autonomy and organization are required for this position.
We look forward to hearing from you !
Because sound matters
Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the magical world of sound to people at every stage of life. As part of the Demant group, a global leader in hearing healthcare with 15,000 people in over 130 countries, we have access to one of the world’s strongest research and development teams, the latest technological advances and insights into hearing care.
Our competencies span more than a century of innovations in sound processing and decades of pioneering experience in hearing implant technology. We work collaboratively with patients, physicians and hearing care professionals to ensure that every solution we create is designed with users’ needs in mind. We share an unwavering commitment to provide innovative solutions and support that enhance quality of life for people wherever life may take them.
Because we know how much sound matters.