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 - Design Assurance will be working in the Design Quality team and must be able to 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.
Primary responsibilities are to:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
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.
Expert professional; works independently as subject matter expert with extensive knowledge in providing quality and engineering decisions in a manufacturing environment.
Leads moderate to significant engineering improvements to quality and manufacturing processes, systems, or products using analytical skills to supplement procedural expertise.
Provide technical oversight to Quality Engineers/Technicians assigned to product development and life cycle management projects. This role is responsible for acting as a formal resource and mentorship for colleagues with less experience, guiding day-to-day work in collaboration with leadership.
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 BS 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 preferred
Product development and manufacturing experience is preferred
Fluency in English is required.
Proven track record of implementing Design Control and Engineering Practice continuous improvements to meet business goals.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
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