Overview
SciPro are supporting a Medical Device company in their search for a Senior Design Assurance Engineer to join on an initial 6-month contract, with the chance of extension. The role focuses on supporting design verification activities and regulatory compliance for FDA submission.
Responsibilities
* Contribute to the creation and execution of design verification testing, including sterilization procedures.
* Participate in validating testing methods to confirm accuracy and reliability of DV testing results.
* Manage and coordinate biocompatibility assessments, ensuring adherence to ISO 10993 standards.
* Assist in evaluating usability studies involving pre-clinical trials, clinicians, and patients.
* Review, approve, and support R&D documentation intended for FDA submission.
* Aid in the preparation and validation of eSTAR submission documents, ensuring accuracy and completeness.
* Maintain compliance with relevant regulatory and quality standards, including ISO 13485, ISO 14971, and IEC 62366.
* Partner with Quality, R&D, Clinical, and Regulatory teams to align verification and validation activities with project timelines.
* Provide guidance and technical expertise during product build and DV&V execution phases.
* Foster effective communication with internal teams and external stakeholders to support the development of customer-focused product solutions.
Requirements
* Experience in medical device verification, validation, or design assurance.
* Knowledge of FDA Design Control requirements and ISO standards (ISO 13485, ISO 14971, ISO 10993, IEC 62366).
* Experience preparing or reviewing regulatory submissions (e.g., FDA 510(k), eSTAR).
* Strong organizational, documentation, and communication skills.
* Ability to manage multiple priorities and work collaboratively across teams.
Please apply by emailing your CV to e.lentell@sciproglobal.com if you meet the criteria.
Job Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance
* Industries: Medical Equipment Manufacturing and Research Services
We are committed to equal employment opportunity. Referrals may enhance interview opportunities.
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