This opportunity is with a consultancy who are seeking a Medical Device Validation Engineer to be the main point of contact for outsourced projects. The right candidate will be able to work autonomously across various aspects of validation, verification, and risk management. This is an ad hoc position and will be carried out remotely.
Validation Engineer job responsibilities include:
- Validate and implement medical device manufacturing processes as assigned.
- Identify equipment/fixture installation qualification requirements.
- Characterization of processes and their outputs/acceptance criteria.
- Written preparation of applicable validation reports that meet regulatory/company standards.
- Must have excellent analytical and problem-solving skills
- Positive attitude, strong work ethic and self-motivated. Ability to handle multiple projects simultaneously and work with minimal supervision.
- Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Quality Management System where applicable.
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Work efficiently across many aspects of Validation including computer services validation and software validation
- Bachelor’s Degree in mechanical engineering, Mechanical Engineering Technology or Biomedical Engineering, or related field
- Minimum 2-5 years’ experience in medical device process development or process validation.
- Proficient in MS Office applications, especially Excel and Word.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.