Design Assurance Engineer

We are looking for an experienced Design Assurance Engineer to join our growing Design QA team.

In this role, you will work closely with R&D, Engineering, and Manufacturing teams to ensure design quality, compliance with applicable regulatory requirements, and effective implementation of design controls throughout the product development lifecycle.

As we advance toward PMA (Premarket Approval), this is an opportunity to play a meaningful role in a critical stage of our product's development.

Responsibilities

• Ensure that design and development activities are performed in accordance with applicable procedures and approved design and development plans.
• Work closely with project teams to provide quality and compliance input throughout the design and development process.
• Review and approve key design and development deliverables, including requirements, design outputs, and verification and validation documentation.
• Support Regulatory Affairs activities, including regulatory submissions, responses to regulatory questions, implementation of new or revised standards, and internal and external audits.
• Participate in project and design review meetings.
• Perform Design Quality activities within the product risk management process, including review and approval of DFMEA and related risk management documentation.
• Support and accompany Engineering Change Orders (ECOs), including assessment and completion of applicable quality activities.
• Provide Design Quality support for design transfer of new products and sustaining changes to Manufacturing, Operations Quality, and Supplier Quality.

QA Manager

• B.Sc. in Engineering, Science, or a related field – Must.
• 3–5 years of experience in Quality Assurance within the medical device industry – Must.
• 2–3 years of hands-on experience with Design Controls – Must.
• Strong knowledge of applicable quality and regulatory requirements, including ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR – Must.
• Strong analytical and problem-solving skills, with excellent attention to detail.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams.
• Strong organizational and follow-through skills.
• Ability to work effectively in a dynamic environment.
• Proficiency in Microsoft Office applications.
• Excellent written and spoken English.

Advantages

• Hands-on experience in Verification and Validation (V&V) activities within the medical device industry – Significant advantage.
• Familiarity with statistical techniques used in verification and validation processes.