Staff Quality Engineer, Design & Reliability Assurance

INTEGRA LIFESCIENCES CORP; Princeton (NJ); On-site; USD 109,250 - 149,500; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Short- and long-term disability

401(k) savings plan

Job summary

INTEGRA LIFESCIENCES CORP is looking for a Staff Design Quality Assurance Engineer to support new product development and manage risks in Tissue Technology. The role involves working independently, guiding teams, and ensuring compliance with regulatory standards.

The ideal candidate has 8+ years of Quality Engineering experience in medical devices, a Bachelor’s degree in Science or Engineering, and expertise in risk management. Employees may enjoy benefits including medical, dental, vision, and a 401(k) savings plan.

Qualifications

• 8+ years of experience in Quality Engineering for medical devices.
• Strong knowledge of risk management and design control.
• Excellent organizational and communication skills.

Responsibilities

• Manage customer and project activities to ensure quality.
• Lead Risk Management and Usability Engineering activities.
• Review and approve development documentation.

Skills

Risk management expertise

Statistical analysis

Regulatory compliance

Project management

Effective communication

Education

Bachelor’s degree in Science or Engineering

Tools

MS Office Suite

Statistical software

TrackWise

Agile product lifecycle management software

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 what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Summary

The Staff Design Quality Assurance Engineer (DQA) is a subject matter expert responsible for the efficient and compliant support of New Product Development (NPD) and Sustaining/Remediation project(s) of varying scope and complexity in the Tissue Technology (TT) division, as well as risk management work for new and existing products. The staff DAQ Engineer works with minimal supervision and guides the work of others to achieve assigned deliverables. The role will interact with design and development partners, participating on cross‑functional project teams through all phases of the product development process, and assisting the technical team with planning, executing, documenting, and communicating testing activities. The role works closely with Product Development, Project Management, Regulatory, Marketing, Manufacturing Facilities and Medical Affairs.

Responsibilities

• Work independently within broad guidelines, policies and the operational plan to impact a range of customer, operational, project or service activities within own team and other related teams.
• Manage complex processes, lead the work of small project teams, formally train and act as a resource for colleagues with less experience.
• Support the design and development of new or improved products in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs.
• Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and application FMEA.
• Author or review for approval other Risk Management Documentation: PSRA, Risk Management Plan/Report, Hazard Analysis, Benefit‑Risk Analysis (BRA).
• Support internal partners in the development of products; review and approve development documentation such as product requirements, schematics, verification, and validation strategy/execution.
• Coordinate, review and approve development documentation created by external partners.
• Lead implementation of SPC programs with Manufacturing and Quality Control as part of Process Validation and Design Transfer.
• Maintain knowledge of and apply statistical analysis to support data‑driven decision making.
• Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
• Develop statistically based sampling plans for Design Verification and Validation, Process Validation, or other studies as deemed necessary.
• Participate in FDA inspections, ISO certification and surveillance audits, customer audits and internal audits as an NPD and/or Sustaining/Remediation subject‑matter expert.
• Write and coordinate efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects.
• Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements.
• Identify and implement opportunities for continuous improvement in the quality system.
• Interact and coordinate activities with other departments, external vendors, and customers.
• Perform other quality systems related duties as required.

Qualifications

• Bachelor’s degree in Science, Engineering (Biomedical, Mechanical or Electrical) or related discipline.
• 8+ years of experience in Quality Engineering, process engineering, or R&D Engineering for medical device, with at least 3 years of direct DQA experience.
• Expert in the application of risk management and design control standards and best practices to NPD and LSM.
• Expertise in statistical sampling and analysis tools/methods to support data‑driven decision making.
• Expert knowledge and understanding of applicable national and international regulations and standards.
• Excellent organizational, verbal and written communication skills.
• Expert with the MS Office Suite, and statistical software.
• Ability to work independently with minimal supervision, guide and coach more junior colleagues.
• Strong prioritization and time‑management skills to meet organizational goals and objectives.
• Experience presenting to external regulatory agencies in audits (e.g., Notified Bodies and FDA).
• Knowledge of TrackWise preferred.
• Knowledge of Agile product lifecycle management system preferred.

Salary and Benefits

Salary Pay Range: $109,250.00 - $149,500.00 USD.

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.

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.

Equal Employment Opportunity

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 you’d like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans.

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 [e-mail].