This Staff Design & Reliability Assurance Quality Engineer is a key functional role within the Design and Reliability Assurance Engineering team. The role involves the process of planning, organizing, leading and reporting all risk management activities through collaboration with cross functional teams. This role is responsible to also lead and coordinate process, practice, procedures and technology adoption for the continuous improvement of risk management work product and deliverables for projects and programs.

The role is also responsible for support of New Product Development (NPD), Sustaining Engineering and Continuous Improvement projects of varying scope and complexity. This individual will collaborate with internal customers and external design and development partners, participating on cross-functional project teams through all phases of the product and process development through commercialization, and support technical teams with planning, execution, reporting and communication of Design and Reliability Assurance work products and deliverables.

This Staff role will be the Subject Matter Expert for Integra products that are electrical/electronic (IEC60601) and software (IEC62304) based.

Responsibilities

• Provide Risk Management and Human Factors leadership, expertise, guidance and supervision during all project phases from initiation through end of life.
• Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management.
• Leads development and implementation of key performance indicators (KPI’s) and metrics for the risk management process and metrics.
• Leads and conducts SWAT assessments in risk management to support continuous improvement across business processes
Lead the process of planning, organizing, leading and reporting all risk management activities through collaboration with cross functional teams.
• Lead and support New Product Development (NPD), Sustaining Engineering and Continuous Improvement projects of varying scope and complexity.
• Collaborates with internal customers and external design and development partners, participating on cross-functional project teams through all phases of the product and process development through commercialization, and supports technical teams with planning, execution, reporting and communication of Design and Reliability Assurance work products and deliverables.

Qualifications

• Bachelor’s degree in engineering (Electrical/Electronic preferred, others considered Mechanical, Systems, Chemical)
• 8 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
• 8 years of experience in a Quality Assurance role for medical device or pharmaceutical product development

• Fluent in French and English
• 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

Salary Pay Range:

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences