Senior Engineer Quality Design Assurance
Senior Engineer Quality Design Assurance
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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 Senior Engineer Quality Design Assurance will work within the Integra Lifesciences CSS Qualityorganization to support the development of new Medical Devices. Working in the Design Qualityteam you should excel in an environment that embraces teamwork change riskbaseddecision making and flexibility. You should be willing to make a significant contribution to amultidiscipline team must be selfmotivated to take actions and have excellent written andverbal communication skills. The position will support line extensions of existing products aspart of the new product development process as well as design related aspects of product andprocess transfers between manufacturing sites. This position will have responsibility for newproduct introduction and development to ensure the highest levels of product quality to the endcustomer. Being able to independently plan and conduct projects and/or assignments withtechnical responsibilities or strategic inputs with moderately detailed instructions from Leaders
and Stakeholders is a musthave.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. Primary responsibilities are to:
- Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners including software requirements and electrical/software architectures
- Lead and/or support risk analysis activities (FMEAs and SHAs). Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example mistake proofing critical control points failure mode effects analysis).
- Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes.
- Proficiency in Design / Process Verification and Validation GR&R Statistical Sampling Plan techniques and Statistical Process Control.
- Conducts and supports the development of test methods in equipment process and product qualifications/validations.
- Support transfer to manufacturing activities both in product development and base business
- Contributes to root cause investigations using various problemsolving techniques and tools and assesses effectiveness of corrective actions.
- Develop inspection methodology and acceptance criteria for inspection sampling plans
- Provide leadership in all areas of the Quality System including but not limited to Corrective & Preventive Actions Risk Management Complaints Post Market Surveillance Nonconforming Materials etc.
- Fulfill design control requirements compliant: software specifications detailed design files design verification and validation test plans risk management DHF protocols and reports in accordance with company procedures FDA and ISO guidelines
- Support Design and Technical Review
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as Research & Development Regulatory Marketing and Manufacturing
- Demonstrate project management and leadership abilities
- Participate to internal and external audits. 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 Masters or other advanced degree is a plus.
- DFSS certification required such as Green or a Black Belts for Design. Green and/or Black belts for process improvement will be considered as well.
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.
This site is governed solely by applicable U.S. laws and governmental regulations. If youd like more information on your rights under the law please see the following notices:
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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 or call us at.
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Required Experience:
Senior IC
Employment Type
Full-Time
