Quality Engineer II - Design & Reliability 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 Quality Design and Reliability Assurance (DRA) Engineer II is 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, specifically the Boston/ Braintree site. The role contributes and

supports the design and development of new and improved products. The (DRA)

Engineer II will interact with external 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 with Product Development, Project Management, Regulatory, Marketing and Medical Affairs.

Essential Duties And Responsibilities

• Understand and support the design and development of new or improved
  
  

products in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs. Support Design Reviews, Technical Reviews, and Gate Reviews.

• Understand and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and application FMEAs.
• Review for approval other Risk Management Documentation: Risk Management Plan/Report, Hazard Analysis, Benefit-Risk Analysis (BRA).
• Support external partners in the development of products, including review
  
  

and approval of development documentation such as product

requirements, schematics, verification, and validation strategy/execution.

• Coordinate and review development documentation created by external
  
  

partners.

• Develop Reliability models for predicting product performance over time
  
  

(where applicable).

• Support implementation of SPC programs with Manufacturing and Quality
  
  

Control as a part of Process Validation and Design Transfer.

• Knowledgeable of and applies statistical analysis to support data-driven
  
  

decision making.

• Work with project teams to develop DOEs and statistically sound tests for
  
  

appropriate support of results.

• Supports developing 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.

• Writing & coordinating 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.

• Maintain 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.
  
  

Desired Minimum Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability

required for this position.

Education & Experience:

• Bachelor’s degree in science, Engineering (Biomedical or Mechanical) or related
  
  

discipline, with 3 years of experience in Quality Assurance role for medical

device or pharmaceutical manufacturing, or equivalent education and years of

experience. Or, master’s degree in science, Engineering (Biomedical or

Mechanical) or related discipline, with 0-2 years of experience, or equivalent

education and years of experience.

• 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 time to meet organizational goals and
  
  

objectives.

• Experience with External Regulatory Agency audits (i.e., Notified Bodies and
  
  

FDA).

• Knowledge of TrackWise preferred.
• Knowledge of Agile product lifecycle management system preferred.
• Demonstrated knowledge and understanding of applicable national and
  
  

international regulations and standards for Design Controls.

TOOLS AND EQUIPMENT USED

• Ability to utilize MS Office Suite
• Ability to work with Minitab for statistical analysis
  
  

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.

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