Job Title: Manufacturing Quality Engineer II (Medical Device)

Pay Rate: $55.14/HR

Duration: 6.6 months

Location: Irvine, CA

Our Client is a Global medical device Manufacturer.

We are looking for Manufacturing Quality Engineer II (Medical Device)

This Pilot Operations Manufacturing Quality Engineer II (Medical Device) role partners on the development of delivery systems for clinical manufacturing for the Transcatheter Heart Valve (THV) Business Unit.

• Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of innovation process is held to the highest standards of integrity and safety.
• You’ll bring your passion for problem-solving and partner with various teams to influence decision-making for a product’s entire lifecycle.
• Your work will enable you to optimize product development to impact patients around the world with pioneering technology.
• Aortic stenosis impacts millions of people globally, yet it often remains underdiagnosed and undertreated.
• We conducted groundbreaking work in transcatheter aortic heart valve replacement (TAVR), pioneering an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery.
• Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence.
• It’s our driving force to help patients live longer and healthier lives.
• Join us and be part of our inspiring journey.
• This Pilot Operations Quality Engineer II role starts with the opportunity to partner on the development of delivery systems for transcatheter heart valves on clinical manufacturing lines for the Transcatheter Heart Valve (THV) Business Unit as a part of the Global Supply Chain.
• This cross functional partner will (1) interact with various functional departments to accomplish compliance and implementation of quality goals with a primary focus to lead quality operations for Pilot manufacturing, (2) work with THV new product development teams in the manufacturing of products for feasibility studies, quality system test samples, Early Human Use, and clinical studies as well as (3) support product transfer from Pilot manufacturing to receiving site manufacturing facilities.

Key Responsibilities:

• Work with new product development teams to help them efficiently navigate the Quality System in order to build quality system test samples and human-use products according to project schedules
• Investigate moderately complex manufacturing product quality and compliance issues (e.g., non-conformances, CAPA, audit observations) for production processes prior to final product release based on engineering principles: analyze results, make recommendations, and develop reports
• Optimize moderately complex manufacturing processes for design and continuous process improvement.
• Identify opportunities to improve manufacturing processes and reduce risk.
• Drive improvements for inspection methods.
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of manufacturing processes
• Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Manufacturing Process Reviews)
• Support test method validation activities for in-process inspections
• Facilitate the Material Review Board to dispose of potentially non-conforming human use products
• Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements

Education and Experience:

• Prior experience in medical device manufacturing or operations is preferred
• Experience with computerized Manufacturing Execution System (MES) preferred
• Bachelor's Degree in a relevant Engineering field, plus a minimum of two (2) years of medical device industry experience required
• Master's Degree in a relevant Engineering field, plus a minimum of one (1) year of medical device industry experience required

Additional Skills & Expectations:

• Strict attention to detail
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical, and critical thinking skills
• Exhibits professional communication (e.g., written and verbal) and interpersonal relationship skills, including consultative and relationship management
• Basic knowledge of statistical techniques and analytics (experience in Minitab preferred)
• Ability to manage competing priorities in a fast-paced environment
• Thrives in a collaborative team environment, including inter-departmental teams and key contacts representing the organization on contracts or projects