Design Assurance Expert
5 days ago
At Ativa Medical, we are seeking a highly skilled Design Assurance Engineer to join our product development team. This key role will play a critical part in ensuring the quality and safety of our medical devices.
We are looking for an individual with 5+ years of experience in Design Assurance in the Life Sciences industry, preferably with a background in Mechanical Engineering or a related field. Your expertise in risk management, design verification planning and execution, supplier management, and material quality activities will be invaluable to our team.
Key Responsibilities:
- Conduct risk analysis activities such as Design FMEAs, Process FMEAs, Hazard Analysis, and User Risk Analysis.
- Manage traceability of design requirements through risk mitigation and design verification.
- Develop technical documentation, including design verification plans, procedures, test protocols, and reports.
- Critical review of design and process documents and records.
- Lead key equipment qualification efforts and supplier management activities.
- Review and evaluate non-conforming materials and work with vendors to correct them.
- Generate inspection procedures for incoming parts and on-site production.
- Review manufacturing documentation for accuracy and clarity.
- Contribute to process validation activities.
Requirements:
- BS in Mechanical Engineering or a related field.
- 5+ years of Design Assurance experience in the Life Sciences industry.
- Proficient knowledge of ISO 13485 and ISO 14971 standards.
- Excellent communication and problem-solving skills.
- Ability to work effectively in a team environment.
What We Offer:
- A competitive salary range of $90,000 - $120,000 per year.
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
- The opportunity to work on exciting medical device projects and contribute to the success of our company.
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