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