Product Design & Development Specialist

As a Product Design & Development Specialist, you will develop and execute the design processes for our medical device products. Your initial focus will be on JULÄINE™, which is based on biodegradable and bioabsorbable Poly-Lactic Acids biomaterials for aesthetic injection. You will also have opportunities to contribute to the development of new products. You will be part of our R&D team, reporting to the R&D Manager and collaborating closely with Regulatory Affairs, Quality Assurance, Clinical Affairs, and Manufacturing throughout the product lifecycle.

Key Responsibilities

Your key responsibilities will include, but not be limited to:

• Define, develop and execute verification and validation (V&V) activities, including usability studies and bench testing.
• Contribute to the design and development of the Design History File (DHF).
• Ensure compliance with applicable standards and regulations (e.g. ISO 13485, EU MDR 2017/745, FDA21 CFR 820.30, ISO 14971 and ISO 10993).
• Translate user needs and clinical insights into design inputs and specifications.
• Translate clinical and product-specific user needs into functional product design requirements.
• Interface internally and externally for packaging and device components.
• Interface with Pre-clinical, Medical, and Clinical departments for e.g. technical documentation, regulatory submissions, etc.
• Working closely with the Manufacturing department to support and participate in the industrialization and scale-up of product designs.
• Oversee pilot and commercial batches to confirm design robustness.

Required Qualifications

• Education: At least a master's degree in biomedical engineering or biomaterials science. A PhD degree is highly beneficial.
• Experience: Around 2–5 years of experience in design & development, working specifically with medical device class III devices and associated design processes.
• Knowledge: Strong understanding of regulatory requirements, including ISO 13485, ISO 14971, ISO 10993, and EU MDR 2017/745. Familiarity with other international regulations, such as FDA 21 CFR 820.30, is considered an advantage.
• Industry experience: Experience working with biopolymer materials, medical aesthetic injectables, or orthopedic implants is highly beneficial.

Personality

• Resilient and adaptable: You bring a resilient, can-do attitude and demonstrate persistence when facing challenges.
• Detail-oriented and organized: Your work is highly organized and precise, with a keen attention to detail and a structured approach to every task to ensure compliance.
• Collaborative: You have strong interpersonal and communication skills to effectively collaborate with internal teams and external stakeholders.
• Independent: You are independent in organizing your daily tasks, able to manage your work in a remote setting.

Other information

This position can be based in any European country and offers flexibility for hybrid or remote work. However, Stockholm (our headquarters) is the preferred location. The role includes regular business travel within Europe and internationally as needed.