Job Summary:

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 clients 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 clients Quality System in order to build quality system test samples and human use product 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 for manufacturing and for 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 Material Review Board to disposition 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 preferred

• Experience with computerized Manufacturing Execution System (MES) preferred

• Bachelor's Degree in relative Engineering field plus minimum of two (2) years medical device industry experience required

• Master's Degree in relative Engineering field plus minimum of one (1) years 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 contact representing the organization on contracts or projects.