Engineering - Engr II
Engineering - Engr II
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Job Description
Job Title: Quality Engineer II
Location: Irvine CA 92614
Duration: 6 Months Contract (Good Possibilities of extension)
Job Description:
- This Pilot Operations Quality Engineer II role partners on the development of delivery systems for clinical manufacturing for the Transcatheter Heart Valve (THV) Business Unit.
- Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products entire lifecycle. Your work will enable you to optimize product development to impact patients around the world with pioneering technology.
Key Responsibilities:
- Work with new product development teams to help them efficiently navigate the Quality System 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
- Bachelors Degree in relative Engineering field plus minimum of two (2) years medical device industry experience required
- Masters Degree in relative Engineering field plus minimum of one (1) year 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.
Trinus Corporation a leading provider of technology solutions and services with over 25 years of experience is a certified WBE/MBE/SBE/SDB firm accredited by WBENC NMSDC and SBA. Our mission is to shape the future of work by aligning the right mix of people process technology and innovation to efficiently meet our clients business objectives. At Trinus we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit. To learn more about us please visit our website
Employment Type
Full Time
