Quality Engineer II Design & Reliability Assurance

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.

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

Salary Pay Range:

$71,300.00 - $97,750.00 USD Salary
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 https://jobs.integralife.com/total-rewards/

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 (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) .

If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities.

All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.

No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.

A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition.

Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement.

Please, no phone calls or emails.

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Required Skill Profession

Other General