Senior Quality Design Engineer I

integralife; Cincinnati (OH); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Group Legal Insurance

401(k) Savings Plan

Job summary

Integra LifeSciences in Cincinnati, OH, is seeking a Senior Engineer I, Quality Design Assurance to join the CSS Quality organization. You will support design quality for medical devices, lead design verification/validation, risk management, and collaborate with R&D, Regulatory, and Manufacturing.

Ideal candidates hold a bachelor’s in engineering and have 5 years in quality assurance for medical devices, with ISO 14971, ISO 13485, FDA QSR knowledge, and strengths in DFSS and Lean methods.

Qualifications

• Bachelor’s degree in engineering (Electrical/Electronic preferred, others considered).
• 3 years in a medical device or regulated industry with knowledge of ISO 14971, EU MDR, FDA QSR and cGMP.
• 5 years in a Quality Assurance role for medical device or pharmaceutical product development.
• Strong analytical and problem-solving skills; ability to work independently.

Responsibilities

• Lead/design medical devices with R&D and external partners, including software requirements.
• Perform risk analyses (FMEAs/SHAs) and apply risk mitigation tools.
• Establish test plans and evaluate data; perform design verification/validation.
• Support design transfers to manufacturing and root cause investigations.
• Maintain Quality System elements including CAPA, risk management, and audits.

Skills

Risk Management

DFSS

Lean

Statistical Methods

Design Verification

Verification & Validation

Communication Skills

Problem Solving

GxP Knowledge

Education

Bachelor's degree in engineering

Tools

MS Office Suite

Statistical Software

Job description

Integra LifeSciences in Cincinnati, OH, is seeking a Senior Engineer I, Quality Design Assurance to join the CSS Quality organization. You will support design quality for medical devices, lead design verification/validation, risk management, and collaborate with R&D, Regulatory, and Manufacturing.

Ideal candidates hold a bachelor’s in engineering and have 5 years in quality assurance for medical devices, with ISO 14971, ISO 13485, FDA QSR knowledge, and strengths in DFSS and Lean methods.