Senior Medical Device Design & Quality Lead

Qualified Recruiter, LLC

Warsaw (IN)

On-site

USD 85,000 - 120,000

Full time

3 hours ago

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Job summary

Qualified Recruiter, LLC is seeking a design control focused engineer for medical devices to ensure design and documentation meet regulatory requirements. You will oversee the DHF, review technical documents, manage traceability, and collaborate with R&D, quality, and other engineering teams to address quality issues.

The role requires a bachelor's degree in engineering or a related field, several years in a regulated medical device environment, and strong knowledge of ISO 13485, ISO 14971, and

Qualifications

Bachelor's degree in engineering or a related scientific discipline is required.
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Responsibilities

Oversee Design History File (DHF) and ensure documentation is complete and compliant.
Review and approve technical documents, design reports, and finished design work.
Manage traceability between design inputs, outputs, risks, and requirements.
Perform QA activities to ensure compliance with ISO 13485, ISO 14971, and FDA 21 CFR 820.
Support design verification through testing and validation activities.
Collaborate with R&D, quality, and other engineering disciplines to address quality issues.
Coordinate risk management activities, including FMEAs, with cross-functional teams.

Skills

Design control

Quality systems

Regulatory compliance

Technical writing

Problem-solving

Education

Bachelor's degree in engineering or related field

Job description

The role requires a bachelor's degree in engineering or a related field, several years in a regulated medical device environment, and strong knowledge of ISO 13485, ISO 14971, and

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