Design Control Engineer – BONESUPPORT

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