Staff Engineer Quality Design Assurance
Staff Engineer Quality Design Assurance
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Salary Not Disclosed
1 Vacancy
Job Description
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 whats 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 riskbased decision making and flexibility. You should be willing to make a significant contribution to a multidiscipline team must be selfmotivated 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 nonstandard sampling plans.
Support 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 Masters or other advanced degree is a plus.
DFSS certification required.
Excellent problem solving decisionmaking 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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Required Experience:
Staff IC
Employment Type
Full-Time
