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The Senior Quality Engineer I – Design & Reliability Assurance (DRA) 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 leads and supports the design and development of new and improved products.  The (DRA) Sr. Engineer 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 closely with Product Development, Project Management, Regulatory, Marketing and Medical Affairs. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

• This role is a seasoned professional engineer with complete and in-depth conceptual knowledge of quality engineering.  They are knowledge of quality engineering best practices to internal processes and manages work with minimal guidance and direction. 

• The Senior Quality Engineer I works to achieve operational targets for specific programs and projects with significant impact on departmental results

• Lead 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.

• Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and application FMEAs.

• Author or 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, review and approve development documentation created by external partners.

• Develop Reliability models for predicting product performance over time (where applicable).

• Lead implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer.

• Maintains knowledge 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.

• 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.

• Authoring & 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.

• 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.

• Works to build consensus within project teams as well as through management of processes and programs.  Explains information with junior members of the team through informal training & work responsibilities

• 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 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent education and years of experience.

• On-site position in Boston, MA with transition to a brand-new state of the art facility in Braintree, MA in 2025.

• 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

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of the position in order to successfully undertake the essential duties and responsibilities of this position.  In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility.  The employee is required to go to all areas of the company.  Must be able to independently travel via car or airplane to domestic and international locations as needed.