Research And Development Specialist

Role: Senior R&D Engineer

Location: Oslo, Norway

Start: Late November

Who: A major client

Speciality: Medical Device

Responsibilities:

• Help lead and manage R&D projects from concept through to launch.
• Design and develop innovative medical devices, utilising advanced engineering principles
• Conduct feasibility studies, risk assessments, and clinical evaluations to validate new products and technologies.
• Collaborate with cross-functional teams, including Quality, Regulatory, and Manufacturing, to ensure successful product development and launch.
• Develop detailed engineering specifications, technical reports, and design documentation.
• Perform root cause analysis and implement corrective and preventive actions (CAPA) to resolve design issues and improve product performance.
• Stay current with industry trends, technological advancements, and regulatory requirements in the medical device sector.
• Support complex cutting-edge medical device systems through prototyping, testing and modelling.
• Develop device design history files (i.e., requirements, risk management, usability files.
• Ensure compliance to industry and international standards.
• Develop verification and validation plans, protocols, and reports.
• Make independent studies, analyses, interpretations, and conclusions.
• Responsible for technical input into project level planning.
• Provide technical guidance to review work plans and advise on unusual features of projects
• Provide technical, project level leadership to engineering assistants or junior engineering staff.

Preferred Qualifications

• Experience focusing on R&D activities relating to medical devices
• Knowledge of ISO 13485, 9001, 14001
• Able to work independently and in a multidisciplinary team environment
• Strong project management skills with the ability to lead multiple projects simultaneously.
• Excellent written and verbal communication skills in English.
• Experience in developing Class II or Class III medical devices.
• Knowledge of CAPA processes and experience in implementing corrective and preventive actions.
• Certification in project management (PMP or equivalent) is a plus.
• Proficiency in additional European languages is a plus.