Senior Design Quality Engineer — Medical Devices

integralife; Cincinnati (OH); On-site; USD 82,000 - 113,000; Full time

Job summary

Integra LifeSciences is seeking a Senior Engineer II, Quality Design Assurance to join the CSS Quality organization. You will support design and development of medical devices, lead risk analysis activities, and ensure robust verification and validation across product life cycles.

Ideal candidates will have ISO14971, 10993 familiarity, and experience delivering design control compliance for FDA/ISO guidelines. Travel up to 50% may be required depending on project needs and partnerships.

Qualifications

• Bachelor’s degree in engineering (Electrical/Electronic preferred, others considered Mechanical, Systems, Chemical)
• 5 years of experience in a medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP.
• Strong analytical skills and a working knowledge of problem-solving methodologies
• Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
• 5 years of experience in a Quality Assurance role for medical device or pharmaceutical product development
• Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology
• Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
• Demonstrates excellent organizational, verbal and written communication skills
• Proficient with the MS Office Suite, and statistical software.
• Must be able to work independently with minimal supervision.
• Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives.

Responsibilities

• Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners, including software requirements and electrical/software architectures
• Lead and/or support risk analysis activities (FMEAs and SHAs). Demonstrate proficiency in applying various risk management and risk mitigation tools and practices
• Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes
• Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
• Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control
• Conducts, and supports the development of test methods in equipment, process, and product qualifications/validations
• Support transfer to manufacturing activities both in product development and base business
• Contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions
• Develop inspection methodology and acceptance criteria for inspection sampling plans
• Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.
• Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines
• Support Design and Technical Review
• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
• Demonstrate project management and leadership abilities
• Participate to internal and external audits.
• Maintain the Quality System

Skills

Risk Management ISO14971

Problem-solving

Statistical analysis

Communication skills

DFSS & Lean

Quality Assurance in medical devices

Independent work

Education

Bachelor's degree in engineering

Tools

MS Office Suite

Statistical software

Job description

Integra LifeSciences is seeking a Senior Engineer II, Quality Design Assurance to join the CSS Quality organization. You will support design and development of medical devices, lead risk analysis activities, and ensure robust verification and validation across product life cycles.

Ideal candidates will have ISO14971, 10993 familiarity, and experience delivering design control compliance for FDA/ISO guidelines. Travel up to 50% may be required depending on project needs and partnerships.