Design Engineer
Design Engineer
Posted on :
05-09-2025
Employer Active
1 Vacancy
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Job Description
Job Description:
- The role involves working with multidisciplinary teams to ensure that medical device development and remediation activities are planned and executed in compliance with design control requirements of the companys quality management system ISO FDA and other regulatory agencies.
Additionally the role includes oversight of the development and maintenance of contact lens device history and risk management files for all assigned products. - The role supports marketed product changes and updates (MOB) and represents design quality on new product development and/or device maintenance of business (MOB) teams.
- Ensure project plans comply with FDA EU MDR and ISO design control requirements.
- Ensure projects meet design development technology transfer validation and post-launch requirements in accordance with the corporate product development process (PDP).
- Manage documentation of product design control activities (e.g. DHFI etc.).
- Manage product risk management requirements as per ISO 14971.
- Review and approve equipment qualifications product/process specifications analytical method qualifications development engineering protocols validation strategies/protocols/reports clinical trial material protocols and batch records QCRs etc.
- Issue QA Product Release authorizations for new products.
- Complete and provide risk management and/or complaint data updates to annual Product Quality Reviews (PQR) revisions to Design Risk Analysis and input to Clinical Evaluation Reports.
- Support post-launch design changes as required.
- Support internal and external audits as a design quality subject matter expert including front room and/or back room support as required.
- Minimum of a BS in quality sciences or a scientific/engineering discipline.
- Chemistry background preferred.
- Minimum 4 years of experience in the medical device or pharmaceutical industry in Quality R&D Engineering or Laboratory environment.
- Familiarity with relevant regulations and standards (e.g. FDA 21 CFR EU MDD/MDR ISO-13485 ISO-14971).
Employment Type
Full-time
Key Skills
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