Medical Device Validation Engineer Jobs in Georgia

Requisition ID: 7166

Job Title: Principal Design Quality Assurance Engineer, Technology Transfer - Alpharetta, GA

Job Country: United States (US)

Here at Avanos Medical, we passionately believe in three things:

• Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
• Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
• Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.

At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. 

Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. For more information, visit www.avanos.com.

Essential Duties and Responsibilities:

The purpose of this position is to focus on the quality-related design transfer activities to ensure the smooth quality and technical transfer of design, products and processes from R&D and sustaining engineering to full-scale (internal or external) manufacturing compliant to medical device standards and regulations such as FDA 21 CFR Part 820 QMSR, ISO 13485, and EUMDR.

The position will focus on the Design Transfer of new to market medical devices and products  going through the full design and development process and of existing products in the field going through design changes. Transfer can be both to internal manufacturing facilities or to qualified suppliers and contract manufacturing organizations.

Key Responsibilities:

• Ensure all design specifications, drawings, and procedures are accurately translated to production specifications and processes with the establishment of a Medical Device File (MDF) and the Bill of Materials (BOM).
• Be responsible for Design Transfer Plans, Reviews and Reports including Final Design Transfer activities.
• Collaborate with R&D, Sustaining Engineering, Technical Operations, Supplier Quality, Manufacturing, Supply Chain, Procurement and Regulatory teams to define quality requirements that will ensure the successful execution of design transfer from the device design to full-scale manufacturing and commercial launch.
• Facilitate process development and Design for Manufacturing (DFM) processes with R&D, Sustaining Engineering and Technical Operations,.
• Partner with Supplier Quality and Supply Chain to facitlitate the qualification of supplied raw materials and components.
• Collaborate with Technciial Operations, Manufacturing Operations and Manufacturing Quality to establish and define incoming, in-process and finished product inspection and testing and acceptance criteria.
• Support  risk analyses (e.g., pFMEA) related to production including the development of control plans.
• Participate in design reviews, providing expert quality input for the transfer phase and ensuring adherence to design control procedures and relevant medical device regulations (e.g., ISO 13485, FDA QMSR).
• Ensure smooth transfer of new products from development to manufacturing, including the establishment of quality control points and documentation which may include:

• • Review and approval of manufacturing test protocols and inspection plans.

  • Review and approval of Test Method Validation and process capability analyses for new manufacturing processes.

  • Review and approval of process validation protocols and reports.

  • Review and approval of work instructions and job aids to ensure quality conformance of the manufacturing and inspection process(es).

• Work with suppliers and contract manufacturersnas needed to support design transfer, ensuring they meet Avanos’ requirements and  quality standards.
• Investigate and resolve quality issues identified during the design transfer phase
• Ensure the design and development files are kept current during the design transfer phase and contribute as needed to the risk management file development.
• Contribute to continuous improvement initiatives within the Quality department and support QMS audits.

Your qualifications

Required:

• Master’s degree in Engineering (e.g., Biomedical, Mechanical, Electrical, Industrial) or a related technical field.
• At least 7 years of experience in quality engineering within the medical device industry, with a strong focus on development and production
• Experience and knowledge of 21 CFR Part 820 QMSR (Quality Management System Regulation), ISO 13485 and ISO 14971
• Experience and knowledge of process validation, supplier quality, test method validation
• Experience with injection molding, extrusion, welding, curing, bonding, sterilization and assembly processes
• Excellent problem-solving skills and the ability to conduct root cause analysis.
• Proficiency in technical report writing and documentation.
• Proven experience with design controls, risk management (FMEA), design verification, and process validation (IQ, OQ, PQ).
• Fluency in English (written and spoken).
• Ability to travel internaltionally up to ~10% of the time.
• Position is based in Alpharetta, GA with the ability to work at least three days a week (ideally Tuesday-Thursday) in officeand be available for onsite workshops when required

Preferred:

• Fluency in Spanish (written and spoken).
• Certifications such as ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt.
• Experience in Design for Manufacturing, Supplier Controls

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.

IMPORTANT: If you are a current employee of Avanos or a current Avanos Contractor, please apply here.

Join us at Avanos
Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.

Make your career count
Our commitment to improving the health and wellbeing of others begins with our employees – through a comprehensive and competitive range of benefits. We provide more than just a salary – our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits.

Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.

Avanos also offers the following:

benefits on day 1

free onsite gym

onsite cafeteria

HQ region voted 'best place to live' by USA Today

uncapped sales commissions