Designer

Qualified Recruiter, LLC; Warsaw (IN); On-site; USD 85,000 - 120,000; Full time

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

Responsible for ensuring a medical device's design and documentation are accurate, complete, and compliant with regulations and internal quality standards. This involves reviewing engineering drawings and documents for errors, managing the design history file, coordinating risk management activities, and verifying design outputs match design inputs through testing and procedures.

Key responsibilities

• Design control and documentation:
• Provide oversight for the Design History File (DHF) and ensure all documentation is complete and compliant.
• Review and approve technical documents, design reports, and completed design work.
• Manage traceability between design inputs, outputs, risk assessments, and requirements.
• Quality and compliance:
• Perform quality assurance activities to ensure compliance with company procedures and global regulations like ISO 13485, ISO 14971, and FDA 21 CFR 820.
• Participate in risk management activities, such as FMEAs (Failure Mode and Effects Analysis).
• Review and coordinate with validation teams for design and test method validations.
• Support regulatory and internal audits.
• Technical review:
• Review engineering drawings, CAD databases, and print packages for accuracy and completeness, identifying any errors or discrepancies.
• Consult on angles, dimensions, and tolerances to ensure designs are manufacturable.
• Cross-functional collaboration:
• Partner with R&D, quality, and other engineering disciplines to address quality issues and ensure design requirements are met.
• Communicate with other team members to provide direction on design improvements.

Qualifications and skills

• Education: A bachelor's degree in an engineering field (\"like Biomedical, Mechanical, or Chemical\") or a related scientific discipline is typically required.
• Experience: Several years of experience in a regulated medical device environment, with a strong focus on design control and quality systems, is necessary.
• Technical knowledge: Familiarity with key standards such as ISO 13485, ISO 14971, and FDA 21 CFR 820 is essential.
• Skills: Strong technical writing, communication, problem-solving, and time management skills are critical. Experience with data analysis and statistical methods is also beneficial.