Job Description
Job Title: Validation Engineer (Windchill PLM) (USC/GC only)
Pay Rate: $60 to $65.67/Hr
Duration: 6 Months
Location: Irvine, CA
Our Client is a Global medical device Manufacturer.
- Investigate manufacturing product quality and compliance issues (e.g., CAPA , non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations, and develop reports
- Conduct validation assessments for design / in-process inspection test methods and evaluate conformance to internal standards
- Identify opportunities for re-design / design of equipment, tools, fixtures, etc., to improve design, test method/manufacturing inspection processes
- Support the development of training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
- Assign support tasks; gives instructions to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work
- Other incidental duties assigned by leadership
Education and Experience:
- Bachelor's Degree in Engineering or a Scientific field, 4 years of related work experience required OR Master's Degree or equivalent internship, senior projects or thesis experience in Engineering or Scientific field, plus 2 years related work experience required
- MUST have fundamental principles of validation knowledge (i.e., test method validation versus process validation, etc.)
- Statistical analysis experience (i.e., presented a data set or feasibility of a TMV, can they understand the data, and any indications it shows)
- Must have technical writing experience
- MUST have Windchill PLM
- Understanding of statistical techniques (Gage R&R, control charts)
- Previous experience working with lab / industrial equipment is required
- Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Learn state-of-the-art validation and statistical techniques
- Good documentation, communication, and interpersonal relationship skills, including negotiating and relationship management skills
- Ability to interface with every and any type of team in a medical device company
- Engineering sustaining work
- Ran small projects for commercial line manufacturing improvements
- Catheter & polymer experience a HUGE plus
- Proficiency in Minitab is a plus!
- Experience adhering to Quality Systems requirements
- Strict attention to detail
- Solid problem-solving, organizational, analytical, and critical thinking skills
- Solid understanding of processes and equipment used in assigned work
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Must be able to work in a team environment, including the ability to communicate with project stakeholders
- Ability to build productive internal/external working relationships
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control
Job Tags
Work experience placement, Internship,