Control Design Engineer

Responsibilities:

- Participating in design reviews, support the R&D teams to ensure standing in the relevant

regulatory standards

- Support in establishment of design files and regulatory submission files to the relevant

authorities

- Participating in risk management process of the products

- Oversee in design changes process.

- Participate in design transfer processes [transfer from R&D to production]

- Support verification and validation processes

- Participating in SW DCR meetings

- Examination and approval of design defect, participate in review meetings design process

- Is part of project core teams

- Support usability processes of the product

- Leading corrective and preventive actions [CAPA] and trending analysis for design processes

- Follow company quality objectives

- preparation for and participation in internal and external audits

Requirements:

- 1ˢᵗ degree in engineering / software engineering / sciences

- At least 2 years’ experience in design control processes or R&D

- Knowledge and experience with manufacturing and design controls in medical devices

- Knowledge of Medical Device Quality Management Systems and FDA QSR an advantage.

- Experience with Software QA and Software Development Life Cycle (SDLC) an advantage

- Excellent interpersonal relationship and understanding of business development environment.

- Clear thinking, good cooperation with other functions in the company [R&D, operation etc.]

- Appropriateness of travelling to the different sites of the company as part of the role