Senior Engineer II - Quality Design & Reliability Assurance

Integra LifeSciences•Cincinnati, OH

About The Position

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 Engineer II, 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. For this Sr II role, ideal candidate will be a Subject Matter Expert with ISO11607, 10993, and functional cascading system requirements to component drawings, balancing the use of Y14.5 with the needs of the business.

Requirements

Bachelor’s degree in engineering (Electrical/Electronic preferred, others considered Mechanical, Systems, Chemical)
5 years of experience of working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP.
Strong analytical skills and a working knowledge of problem-solving methodologies
Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
5 years of experience in a Quality Assurance role for medical device or pharmaceutical product development
Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology
Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
Demonstrates excellent organizational, verbal and written communication skills
Proficient with the MS Office Suite, and statistical software.
Must be able to work independently with minimal supervision.
Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives

Responsibilities

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.
Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
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