Senior 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 Senior Quality Engineer I 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, improvements of existing products as part of the design change process, support supply chain concerns 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• 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 design changes and improvements to Medical devices in close collaboration with R&D and external partners

• 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

DESIRED MINIMUM QUALIFICATIONS

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

• Bachelor’s degree (or equivalent) in Engineering or related technical/scientific field with a minimum of 5 years of related experience.

• Experience in medical device product development / process and product validation

• Knowledge of Quality Engineering/Scientific methods and techniques.

• Expertise in measurement techniques and sampling plan definition (for example, mechanical, optical, gages, automation).

• Experience managing projects and demonstrating leadership abilities.

• Excellent problem solving and decision-making is required.

• Root cause analysis skil