Senior Design Assurance Engineer II - Medical Devices

Integra LifeSciences; Mansfield (MA); On-site; USD 94,000 - 130,000; Full time

Job summary

Integra LifeSciences is seeking a Senior Engineer II, Quality Design Assurance to lead design and development activities for medical devices. You will collaborate with R&D and external partners, perform risk analyses, apply statistical methods, and ensure compliance with design control requirements across the product life cycle.

The role emphasizes leadership, cross-functional communication, and execution of test plans, validation, and transfer to manufacturing, with a focus on ISO 14971,

Qualifications

• Bachelor’s degree in engineering; Electrical/Electronic preferred; others considered.
• 5 years of experience in a medical device or regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD, IEC 62366, ISO 13485, FDA QSR and cGMP.
• Strong analytical skills and 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 in Risk Management, processes, tools and technology.

Responsibilities

• Lead and/or support the design and development of medical devices with R&D and external partners, including software requirements and architectures.
• Lead and/or support risk analysis activities (FMEAs and SHAs) with risk management tools and practices.
• Apply statistical methods and process/design excellence tools to establish test plans and evaluate data and processes.
• Demonstrate proficiency in DFSS, Lean and process improvement techniques.
• Proficiency in Design/Process Verification and Validation, GR&R, SPC and sampling plans.
• Develop test methods for equipment, process, and product qualifications/validations.
• Support transfer to manufacturing activities in development and base business.
• Contribute to root cause investigations and corrective actions.
• Develop inspection methodology and acceptance criteria for inspection sampling plans.
• Provide leadership in the Quality System (CAPA, Risk, Complaints, Post-Market Surveillance, etc.).
• Fulfill design control requirements per FDA and ISO guidelines; manage documentation and reviews.
• Support Design and Technical Review; communicate across departments.
• Demonstrate project management and leadership capabilities; participate in audits.

Skills

Quality Assurance

Risk Management

Statistical Analysis

DFSS

Lean Process Improvement

GR&R

Statistical Sampling Plan

Statistical Process Control

Project Leadership

Communication Skills

Education

Bachelor’s degree in engineering (Electrical/Electronic preferred)

Tools

MS Office

Statistical Software

Job description

Integra LifeSciences is seeking a Senior Engineer II, Quality Design Assurance to lead design and development activities for medical devices. You will collaborate with R&D and external partners, perform risk analyses, apply statistical methods, and ensure compliance with design control requirements across the product life cycle.

The role emphasizes leadership, cross-functional communication, and execution of test plans, validation, and transfer to manufacturing, with a focus on ISO 14971,