Anders Molin Email & Phone Number

Hillerød, Capital Region, Denmark

Ballerup, Capital Region, Denmark

- Develop and maintain design control documentation to support development of combination products - Prepare submission documentation to Health Authorities and Notified Body and support in the Q&A phase- Plan and prepare documentation packages for and participate in meeting with health authorities (FDA)- Participate in implementation of ISO 11608-1:2022.

Hillerød, Capital Region, Denmark

Main responsibilities include:- Establish and maintain development plans for development of combination products- Ensure compliance with design control regulations, e.g. MDD/MDR, ISO 11608, ISO 14971, IEC 62366 and FDA 21 CFR 820.30- Coordinate design control activities within system engineering, risk management, design verification and design validation.

Hillerød, Denmark

Main responsibilities included:- Establish design input and output for combination products- Develop and maintain project documentation in compliance with design control regulations, e.g. MDD/MDR, ISO 14971, IEC 62366 and FDA 21 CFR 820.30- Drive and document design control activities such as verification planning and facilitating design reviews- Provide.

Hillerød

• Main responsibilities included:
• Coordinating design validation activities in a range of development projects with medical devices and combination products
• Plan and execute formative and summative usability tests (design validation)
• Prepare usability related input to written interactions with the FDA
• Prepare usability reports for health authorities as part of submissions for approval of medical devices and combination products (design validation)
• Participate in teleconferences and face-to-face meetings with FDA in preparation of summative usability tests for medical devices and combination products

Hillerød

Hillerød

• Main responsibilities included:
• Integration of hardware in insulin pen-injector
• Coordination of verification activities, including test planning, development of test methods and equipment and test execution
• Handling technical aspects and questions related to customer complaints for pen-injectors
• System engineer for a platform of pen-injectors, including design control, change requests and verification activities
• Participate in internal and external audits as system engineer and usability engineer

Copenhagen Area, Denmark

• Main responsibilities included:
• Development of sheet metal parts in mobile phones
• Cross-functional work with integration of hardware components in mechanical constructions
• Development of flexible PCB designs used in mobile phones
• Prepare and mature mechanical solution for mass-production
• Create and optimise tolerance calculations, risk analysis and other types of documentation

Copenhagen Area, Denmark

Hillerød, Denmark

• Main responsibilities included:
• Development of a pen-injector needle with a safety feature which ensures, that the needle can only be used once, and thereby reduce the risk of cross contamination between patients and healthcare providers
• Development of the needle involved designing plastic components including 2k moulding, moulding optimisations, DFA activities, ultra-sound welding, design verification, design control
• During the development process, from the early concept selection to launch of the product, the work required close collaboration with several internal and external stakeholders, including production, QA, RA and.
• Work also included working as a system engineer in supporting the production of pen-injector needles, where the main tasks involved design control, product optimisations and production issues

Master Of Science (M.Sc.), Mechanical Engineering

Master Of Science (M.Sc.), Mechanical Engineering

Education record

Education record