Design Assurance Engineer

Neurent Medical is seeking a highly motivated and experienced Design Assurance Engineer to join our team. This individual will play a key role in supporting the lifecycle of our commercially released medical device products. The role involves managing design changes, ensuring continued compliance with risk management and design control requirements, and supporting complaint investigations to uphold the safety and effectiveness of our devices.

DUTIES AND RESPONSIBILITIES:

Support sustaining commercial projects from a Design Assurance perspective; direct involvement in making sure products are maintained through the full product lifecycle and that these products comply with global standards.

Lead and execute product / material design changes for commercially released products in accordance with regulatory and internal quality system requirements; experience and expertise in assessing for design, usability, sterilisation, biocompatibility and clinical impact.

Provide DA technical direction / input to process changes for commercially released products in conjunction with R&D and Manufacturing Engineering.

Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.

Maintain and update the risk management file for post-market products, ensuring all identified risks are adequately documented and mitigated and assessing for product / material / process changes.

Generation of Design Verification (DV) plans, protocols & reports and execution of DV testing to support product / material design changes and collection of shelf-life data to support regulatory submissions.

Ensure continued design control compliance (per FDA 21 CFR 820.30 and ISO 13485), including design history file (DHF) maintenance, verification/validation planning, and traceability.

Support complaint handling by participating in technical investigations, root cause analysis, and determining appropriate corrective and preventive actions (CAPA).

Maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, and commercialisation activities.

Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures. Generate and approve change requests.

Assist in regulatory submissions and audits by providing documentation and subject matter expertise related to design assurance.

Collaborate cross-functionally with engineering, manufacturing, regulatory affairs, and quality to implement and document product changes. Contribute to establishing strong working cross functional relationships across the organization and with partners within a complex technical environment.

Drive continuous improvement initiatives within the design assurance processes.

Mentor junior engineers as needed.

Education/Experience

We are seeking a qualified individual with a minimum Bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science).

Minimum 2-3 years of experience in design assurance, quality engineering, or product development in the medical device industry.

Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and relevant guidance documents.

Experience with design control and risk management throughout the product lifecycle, including relevant experience in some or all of the following: design verification execution, biocompatibility, human factors and usability, statistical analysis, sterilisation.

Experience with post-market surveillance, complaint investigations, and CAPA systems.

Established and productive individual contributor who works independently with general supervision on larger, moderately complex projects and assignments.

Excellent analytical, communication, and documentation skills.

Detail-oriented with the ability to manage multiple tasks in a fast-paced environment.

Dynamic team player who can work effectively and proactively on cross-functional teams Insert and format text, links, and images here.