Design Assurance Engineer: NPI & Medical Devices

Abbott

Republic (WA)

On-site

USD 60,000 - 100,000

Full time

14 days+

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Job summary

Join a forward-thinking company as a Design Assurance Engineer, where you will play a crucial role in shaping new product development. This position offers the opportunity to implement best practices in design controls, ensuring compliance across various teams in a dynamic environment. You will be instrumental in standardizing project deliverables and supporting innovative diagnostic device projects. With a commitment to quality and regulatory excellence, this role provides a platform for impactful contributions in a diverse cultural setting. If you are passionate about enhancing product quality and driving compliance, this is the perfect opportunity for you.

Qualifications

  • 2-3 years of Quality Engineering/Design Assurance experience in a regulated environment.
  • Formal training in Medical Device Risk Management and Process Validation is beneficial.

Responsibilities

  • Promote awareness of regulatory and customer requirements across the organization.
  • Support new test development and ensure compliance with design control policies.

Skills

Data Analysis
Communication Skills
Team Collaboration
Problem Solving

Education

Degree in Science, Engineering or Technology

Tools

ISO13485
FDA Regulations

Job description

Join a forward-thinking company as a Design Assurance Engineer, where you will play a crucial role in shaping new product development. This position offers the opportunity to implement best practices in design controls, ensuring compliance across various teams in a dynamic environment. You will be instrumental in standardizing project deliverables and supporting innovative diagnostic device projects. With a commitment to quality and regulatory excellence, this role provides a platform for impactful contributions in a diverse cultural setting. If you are passionate about enhancing product quality and driving compliance, this is the perfect opportunity for you.
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