Arbetsbeskrivning

Come and join BONESUPPORT as Design Control Engineer!

This is an opportunity to apply your expertise in design control, risk management and technical documentation, contributing to the continued development and lifecycle management of innovative medical devices.

About BONESUPPORT

BONESUPPORT™ AB is an innovative and growing medical device company based in Lund, Sweden. The company develops and commercializes injectable bio-ceramic bone graft substitutes for the treatment of bone disorders.

BONESUPPORT's products are based on its patented CERAMENT® technology platform, with the aim of improving treatment outcomes for patients.

About the role

As Design Control Engineer, you will join the Development & Engineering department and play an important role in product lifecycle management, with a focus on design control, change control and risk management.

You will contribute to maintaining and developing the technical documentation for BONESUPPORT's products, ensuring compliance with applicable regulatory requirements, standards and internal procedures throughout the product lifecycle.

Risk management is an important part of the role, and you will have the opportunity to contribute your knowledge and experience to further strengthen this area within the organization.

Your main responsibilities will include:

• Manage and support design control and change control activities for existing products and product improvements.
• Prepare, review and maintain technical documentation, including design and development documentation.
• Participate in risk management activities, including risk assessments and FMEA, in accordance with ISO 14971.
• Plan, conduct and document verification and validation activities.
• Support requirements management and maintain traceability between requirements, risks and verification activities.
• Contribute to usability engineering activities in accordance with applicable standards.
• Perform gap analyses related to updated regulatory requirements, standards and guidelines.
• Develop and maintain technical procedures, specifications and other quality system documentation.
• Collaborate with cross-functional teams to support product changes, investigations and continuous improvements.

You will work closely with Quality Assurance, Regulatory Affairs, R&D, Operations and other functions, as well as external partners.

Qualifications

We are looking for a structured and motivated engineer with practical experience in design control and technical documentation within the medical device industry.

To succeed in this role, we believe you have:

• A technical academic background at Bachelor's level or higher.
• Relevant experience from the medical device industry.
• Hands-on experience with design control, change control and technical documentation.
• Experience in requirements management and design verification activities.
• Knowledge of risk management according to ISO 14971, including FMEA and risk management documentation.
• Knowledge in Usability engineering according to IEC 62366.
• Good understanding of applicable medical device regulations and standards (EU and US).
• Strong technical writing and documentation skills.

Preferred qualifications

It is an advantage if you also have experience or knowledge in:

• Implantable medical devices.
• Sterilization processes.
• Statistical methods and test method development.

Personal qualities

We believe you are structured, analytical and detail-oriented, with a practical and solution-focused approach to your work.

You are comfortable taking responsibility for your tasks and driving activities forward independently, while recognizing the importance of collaboration and knowledge sharing.

You communicate clearly, take initiative and enjoy working with colleagues from different functions. You are motivated by continuous improvement and contributing to the development of both products and processes.

Why BONESUPPORT?

At BONESUPPORT, you will have the opportunity to work with innovative medical devices that make a difference for patients.

You will join a growing company with dedicated colleagues and a collaborative working environment. The role offers an opportunity to apply and further develop your expertise in design control and risk management while contributing to the continued development and maintenance of BONESUPPORT's products.

Location: Lund, Sweden

Application

SKÅNESTOR is managing the recruitment process on behalf of BONESUPPORT.

Please apply directly through this advertisement. For questions, please contact SKÅNESTOR at [email protected].