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Job Summary:
In this role, you will be responsible for generating DHF documentation and managing R&D activities, including all stages according to Design Controls (R&D, V&V, etc.). In this role you will be involved in the design of newly developed medical devices as well as supporting existing designs. The position is temporary for 7 months maternity leave replacement.
Essential Duties and Responsibilities:
Create, maintain, and update Design History File content per Design Control. Initiate, perform, and approve R&D technical design reviews. Author, review and approve product development / Verification / Risks / R&D related documentation.
Provide technical knowledge of system engineering and its application to developing cost effective, reliable, and high-quality solutions that address customer and business needs.
Participate in applicable risk management activities, identify potential risks and find solutions to prevent these and/ or solve these.
Work in collaboration with team members and functional groups.
Generate and/or review and/or approve verification and/or validation plans, protocols, and reports, including test method validation, Engineering studies and usability studies as assigned including R&D support in test methods activities.
Define, drive and manage change management and communications activities that support assigned projects.
Shared team responsibilities of DHF, device/system performance, quality, and technical implementation.
Other duties as assigned.
Bachelor of science in Biomedical/Mechanical/Materials engineering (at least) from a 4 years college.
Experience: 2-4 years experience in R&D positions, Medical device experience- an advantage.
Working under GMP environment- an advantage
Experience with MS Office programs. CAD and Statistical software- an advantage.
Preferred Knowledge, languages, Skills and Abilities:
Working under constant pressure to deliver
Ability to work independently and in a cross-functional team.
Good communication skills
Excellent verbal and written communication skills in English.
Technical abilities
Creativity
High learning curve
Organized
Multitasking
Relevant work history and/or experience may be considered in lieu of degree.
