Senior Quality Design Engineer - Medical Devices

Integra LifeSciences Corporation; Cincinnati (OH); On-site; USD 71,000 - 98,000; Full time

Job summary

Integra LifeSciences Corporation in the United States seeks a Senior Engineer I, Quality Design Assurance to lead design verification, risk analysis, and validation activities for new medical devices, collaborating with R&D and manufacturing.

The role emphasizes ISO 14971, 10993, DFSS, GR&R, and Design Control; strong communication and project leadership required; multi-disciplinary collaboration; location in the US; salary range applies.

Qualifications

• Bachelor's degree in engineering or related field.
• 3+ years in medical device or regulated industry with knowledge of ISO 14971, EU MDR, MDD, IEC 62366, ISO 13485, FDA QSR and cGMP.
• Strong analytical and problem-solving skills; excellent communication.

Responsibilities

• Lead/design medical devices in collaboration with R&D and external partners, including software requirements and architectures.
• Lead risk analysis activities (FMEA, SHA) and apply risk management tools.
• Apply statistical methods and process/design excellence tools to establish test plans and evaluate data.
• Work with DFSS, Lean, and process improvement techniques.
• Design/Process Verification and Validation, GR&R, Sampling Plans, and SPc.

Skills

Analytical skills

Problem-solving

Communication

Education

Bachelor's degree in engineering

Tools

MS Office Suite

Statistical software

Job description

Integra LifeSciences Corporation in the United States seeks a Senior Engineer I, Quality Design Assurance to lead design verification, risk analysis, and validation activities for new medical devices, collaborating with R&D and manufacturing.

The role emphasizes ISO 14971, 10993, DFSS, GR&R, and Design Control; strong communication and project leadership required; multi-disciplinary collaboration; location in the US; salary range applies.