Design Engineer

• 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 company's quality management system, ISO, FDA, and other regulatory agencies.

• 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).

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