Staff Engineer, Quality Design Assurance

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Staff Quality Engineer will work within the Integra Lifesciences CSS Quality organization to support design changes and improvements on our range of Neurosurgical Medical Devices and lead a team of Quality Engineer. 
Working in the Design Quality team, you should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. You should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take action, and have excellent written and verbal communication skills.  The position will support line extensions of existing products as part of the new product development process, as well as design related aspects of product and process transfers between manufacturing sites.  This position will also have responsibility for providing oversight to Quality Engineer/technicians assigned to new product introduction and development to ensure the highest levels of product quality to the end customer.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Draw on experience with root cause analysis, design verification/validation, statistical methods and analysis, technical specification review, experimental design, component derating/DFFS, point and set based design principles as well as reliability engineering principles to complete new product development, validation, design transfer and new product introduction in the Neuroscience and Specialty Surgical domains.

• Provide technical oversight to Quality Engineers/Technicians assigned to product development and life cycle management projects.

• Project review at the site level, assignment of resources and discussion to define budget for Mansfield Design & Reliability Assurance group

• Apply statistical methods and process/design excellence tools to establish test plans, evaluate test data and processes for test methods, process and design verification/validations.

• Develop and deploy Global Operating Procedures for Integra LifeSciences across the Design Control, Validation and Design Transfer domains.

• Provide training as part of early adoption, anticipate changes, and provide feedback to support organizational transformation within the Design Assurance and Reliability domain.

• Support life cycle management activities to sustain complex products.

• Plan and conduct validation activities.

• Develop methodologies and acceptance criteria for design of experiments and sampling plans.

• Interpret standard and non-standard sampling plans.

• Support execution of strategic vision or plan by collaborating with other quality leaders to identify required Quality Engineering skills and competencies.

• Support functional and project budget planning and compliance

• Represent the Design Assurance and Reliability Engineering function during internal and external audits including FDA

• Maintain the Quality System

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• A minimum BSc degree in Engineering (Mechanical, Electrical, Systems ) or related technical discipline with a minimum of 10 years of experience in related field is required. A Master’s or other advanced degree is a plus.

• DFSS certification required.

• Excellent problem solving, decision-making, and root cause analysis skills are required

• Interpersonal skills that foster conflict resolution as it relates to technical situations are required

• Previous experience in a medical device or a 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, verification, validation and design failure modes and effects analyses

• Knowledge of statistical methods, techniques 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