R&D Product Development Specialist Materials

Medela Switzerland (HQ); Baar; Presencial; CHF 110.000 - 170.000; Jornada completa

Descripción de la vacante

Medela is seeking an R&D Product Development Specialist Materials to advance medical device materials and lifecycle management in a regulated environment. You will define material requirements, select candidates, and lead testing with internal teams and external partners to ensure quality and safety.

You will contribute to design reviews, risk assessments and FMEA, document technical evidence, and maintain traceability.

Formación

• Bachelor in Material Science, Biomedical Engineering, Toxicology, Chemistry, Pharmacy or Human Biology.
• At least 2 to 4 years of professional experience in medical technology or materials science.
• Familiar with working in a regulated environment.
• Fluent in German or English; second language with very good written and spoken skills.

Responsabilidades

• Support the development and lifecycle management of medical devices within scope, timelines, quality requirements and regulatory standards.
• Define and evaluate material requirements based on product, user, safety and regulatory needs.
• Select and assess materials for medical device applications, considering biocompatibility, sterilization, reprocessing, manufacturability and supply continuity.
• Provide material expertise in design reviews, risk assessments, technical evaluations, and FMEA activities.
• Plan, coordinate, execute and document material testing and verification activities with internal and external stakeholders.
• Analyze test results, assess technical evidence, and ensure compliance with defined requirements and acceptance criteria.
• Prepare and maintain technical documentation, including specifications, assessments, reports, and traceability records.
• Evaluate product, process, supplier, and regulatory changes for impact on material compliance, safety and performance.
• Collaborate with Product Development, Quality, Regulatory Affairs, Operations, Procurement, Manufacturing and external suppliers.
• Contribute to continuous improvement of processes related to material compliance, biological safety and product quality.

Conocimientos

Regulatory experience

Materials science

Biomedical engineering knowledge

Educación

Bachelor in Material Science, Biomedical Engineering, Toxicology, Chemistry, Pharmacy or Human Biology

Descripción del empleo

R&D Product Development Specialist Materials (m/f /d)

Are you interested in working for a company that is passionate about its customers? That lives its values and nurtures its employees? Then Medela is the company for you.

Your responsibilities

Support the development and lifecycle management of medical devices, ensuring projects are delivered within scope, timelines, quality requirements, and applicable regulatory standards. Define and evaluate material requirements based on product, user, safety, and regulatory needs. Select and assess materials for medical device applications, considering biocompatibility, sterilization, reprocessing, manufacturability, and supply continuity. Provide material expertise in design reviews, risk assessments, technical evaluations, and FMEA activities. Plan, coordinate, execute, and document material testing and verification activities in collaboration with internal stakeholders and external partners. Analyze test results, assess technical evidence, and ensure compliance with defined requirements and acceptance criteria. Prepare and maintain technical documentation, including specifications, assessments, reports, and traceability records. Evaluate product, process, supplier, and regulatory changes for their impact on material compliance, product safety, and performance. Collaborate closely with Product Development, Quality, Regulatory Affairs, Operations, Procurement, Manufacturing, and external suppliers. Contribute to the continuous improvement of processes, procedures, and best practices related to material compliance, biological safety, and product quality.

Your impact

Ensure materials and components meet the highest standards of quality, safety, performance, and regulatory compliance. Support investigations of material-related non-conformities, complaints, and production issues, including root cause analysis and corrective actions. Stay current with relevant medical device regulations, standards, guidance documents, and emerging material technologies to support informed decision-making.

Your qualifications

Bachelor in either of these fields: Material Science, Biomedical Engineering, Toxicology, Chemistry, Pharmacy or Human Biology. Experience At least 2 to 4 years professional experience as a development engineer in medical technology or as materials science specialist. Familiarity of working in a regulated environment, ideally in medical technology. Other knowledge German or English fluently, the second language with very good knowledge in word and writing.

Your opportunity

At Medela, you will be joining a global community of colleagues, united by the purpose that drives our business: helping people. Medela exists to advance human health and wellbeing through knowledge-based and innovative human milk and medical vacuum solutions. Our employees are empowered to serve this purpose in a family-owned company that is growing rapidly around the world. We value intensive exchanges, diverse perspectives, and unbureaucratic decisions. You will have the opportunity to develop at an international level, and witness the direct impact your work has on our company’s success.

About Medela

Medela is the #1 breast pump brand* and one of the leading companies in medical vacuum technologies respected and trusted by doctors and healthcare professionals from around the world. A family-owned company with a global presence in Europe, America and Asia, Medela has 21 locations worldwide and a sales network of independent partners in over 100 countries. The company has production and warehouse facilities in Baar (Switzerland), McHenry (Illinois, USA) and Changzhou (China). With over 1800 employees, Medela improves health and well-being through the pursuit of knowledge and the development of innovative products and services, empowering mothers, babies and patients to live their lives to the fullest. Founded in 1961 by Olle Larsson, his son Michael Larsson serves as Chairman of the Board of Directors since 2001. Thomas Golücke is the CEO of the company since 2024. "By creating a culture of belonging, we are building engaged teams that work together to serve our customers as one Medela family".