Staff Quality Engineer - Design Assurance

Integra Lifesciences Holdings Corporation • Mansfield, MA

400d

About The Position

The Staff Quality Engineer - Design Assurance will play a crucial role in the Design Quality team, focusing on ensuring product quality through various engineering processes. This position involves supporting new product development, design transfers, and providing oversight to Quality Engineers and technicians. The ideal candidate will thrive in a collaborative environment, demonstrating strong problem-solving skills and a commitment to quality in the healthcare sector.

Requirements

• A minimum BS degree in Engineering (Mechanical, Electrical, Systems) or related technical discipline with at least 10 years of experience.
• DFSS certification is required.
• Excellent problem-solving, decision-making, and root cause analysis skills.
• Interpersonal skills for conflict resolution in technical situations.
• Previous experience in a medical device or healthcare discipline is required.
• Expert knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485, IEC 62366, EU MDD/MDR, and ISO14971.
• Expert Quality Engineering skills with a proven track record in design optimization and validation.
• Knowledge of statistical methods and their application to New Product Development.
• Experience with Blueprint reading/literacy including GD&T is preferred.
• Working knowledge of material science and mechanical product knowledge is preferred.
• Fluency in English is required.

Nice To Haves

• Master's or other advanced degree is a plus.
• Experience with product development and manufacturing is preferred.

Responsibilities

• Perform root cause analysis, design verification/validation, and statistical methods for new product development.
• Lead engineering improvements to quality and manufacturing processes using analytical skills.
• Provide technical oversight and mentorship to Quality Engineers/Technicians on product development projects.
• Conduct project reviews, resource assignments, and budget discussions for the Design & Reliability Assurance group.
• Apply statistical methods to establish test plans and evaluate test data for verification/validations.
• Develop and deploy Global Operating Procedures across Design Control, Validation, and Design Transfer domains.
• Provide training and feedback to support organizational transformation within the Design Assurance domain.
• Support life cycle management activities for complex products.
• Plan and conduct validation activities and develop methodologies for design of experiments.
• Represent the Design Assurance function during internal and external audits.

Benefits

• Equal employment opportunities regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Management of Companies and Enterprises
• Education Level: Bachelor's degree