Upholding the company values is extremely important to Sonova, we take the health and safety of our employees, patients, customers and their families very seriously. To that end, we have concluded that the best way to ensure the safety of these individuals is to mandate that all of our newly-hired employees be fully vaccinated for COVID-19. Therefore, when considering whether to apply for this position, please know that in order to become employed by Sonova (if otherwise eligible), you must provide satisfactory proof, such as a vaccine card or other documentation, that you are fully vaccinated for COVID-19. You will not be required to provide this proof unless and until you receive a formal job offer from Sonova. Please also know that Sonova will provide accommodations to qualified individuals who cannot receive the COVID-19 vaccination because of a sincerely held religious belief or due to a medical issue or pregnancy.
What you'll do:
- Develop and implement biocompatibility evaluation strategies and reports.
- Manage and execute chemical characterization studies, toxicological evaluations and biocompatibility testing in compliance with ISO 10993.
- Document test results in a database and justify these towards authorities.
- Support R&D for selection and definition of materials for different applications by ensuring the safety of the medical devices.
- Assessment of biocompatibility of medical class III products (implants and external devices).
- Organize and plan chemical characterization studies and biocompatibility tests with external contract research organizations.
- Analysis and documentation of test results.
- Collaborate with the regulatory department to ensure that materials and tests meet all applicable environmental and regulatory standards (ISO10993).
- Present and justify materials and process selection towards authorities.
- Evaluation and introduction of new plastic resins, metals, rubbers, silicones and adhesives.
- Documentation of new materials in Agile PLM.
- Establish relationship with external suppliers and coordinate material availability at suppliers.
- Execute and manage chemistry tests, such as corrosion or substance release studies, to support research activities, product development and validation tasks.
- Technical support for sourcing decisions.
- Know-how transfer between different departments.
What you bring to the team:
- Expert knowledge in biocompatibility and risk assessment for medical devices (ISO10993).
- Expert knowledge in material properties and chemical formulations (plastic, metal, rubber, silicone, adhesive)
- Knowledge and understanding of polymer chemistry, analytical chemistry principles, theories and concepts
- Knowledge of RohS and REACH compliance requirements is a plus.
- Familiar with Quality Management processes according to ISO13485
- Good project management skills
- Hands on experience with Microsoft Office and Agile PLM
- Innovative, hands-on, confident and clear communicator, with a genuine passion for products and ability of multi-tasking.
- Excellentinterpersonal and motivational skills with ability to provide mentorship in own area of expertise.
- Master or bachelor degree in chemistry, chemical engineering, material science, material engineering, or equivalent area.
- Min. 3-5 years of professional experience in the area of biocompatibility testing and material selection.
- Expert understanding of FDA and EU regulatory requirements for medical device industry.
- Essential industry background includes medical devices or pharmaceutical products.
- Exciting and challenging work environment
- Comprehensive benefits package
- Training and development opportunities - we believe every employee deserves a development plan. Come, learn, and grow with us!
Don't meet all the criteria? If you're willing to go allin and learn we'd love to hear from you!
We love to work with great people and strongly believe that a diverse team makes us better. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.
We thank all applicants in advance; however only individuals selected for an interview will be contacted. All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Director, Human Resources.