Jobs for People with MS: National MS Society

Changing lives. Building Careers.

Joining us is a chance for you 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, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

The Senior Engineer, Quality Design Assurance will work within the Integra Lifesciences CSS Quality organization to support the development of new Medical Devices. 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 actions, 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 have responsibility for new product introduction and development to ensure the highest levels of product quality to the end customer. Being able to independently plan and conduct projects and/or assignments with technical responsibilities or strategic inputs with moderately detailed instructions from Leaders

and Stakeholders is a must-have.

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 problem-solving 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 Master's 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, 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.