What are the responsibilities and job description for the Engineer II position at TalentBurst, an Inc 5000 company?
Position: Engineer II, Req#: 10541-1
Location: Irvine, CA (100% Onsite)
Duration: 9 Months Contract
Job Description
What does your group do? New product development, surgical valves
Does your team use any specific technology/software you want us to look out for? Windchill (document control). A plus – SolidWorks, Minitab, Keyence
What would stand out for you in a resume? Experience in product development/quality engineering of surgical valves within last 3 years, independent/reliable
What does the ideal candidate need to possess to be successful in this role? Quality focused, experience in new product development and risk management remediation
What will a typical workday look like? Independent/collaborative assignments, daily stand-ups
What will the work schedule be? Can any overtime be expected? 8 hours (start between 8 am and 9 am), no overtime, 5 days onsite
What are your top 3 required technical skills? Must haves? Engineering or related fields, Experience in regulated industry (e.g. ISO 13485/5840) or with quality stds (eg. ISO), Analytical and detail-oriented
What are nice-to-have skills? Experience in surgical valve-related fields, Risk documentation development/maintenance, Understanding of statistical process
The main function of a quality engineer is to research and test the design, functionality and maintenance of products, equipment, systems and processes and develop quality standards. A typical quality engineer has the ability to read and interpret blueprints and evaluate product integrity and standards.
Education And Experience
Job #: 25-26897
Location: Irvine, CA (100% Onsite)
Duration: 9 Months Contract
Job Description
What does your group do? New product development, surgical valves
Does your team use any specific technology/software you want us to look out for? Windchill (document control). A plus – SolidWorks, Minitab, Keyence
What would stand out for you in a resume? Experience in product development/quality engineering of surgical valves within last 3 years, independent/reliable
What does the ideal candidate need to possess to be successful in this role? Quality focused, experience in new product development and risk management remediation
What will a typical workday look like? Independent/collaborative assignments, daily stand-ups
What will the work schedule be? Can any overtime be expected? 8 hours (start between 8 am and 9 am), no overtime, 5 days onsite
What are your top 3 required technical skills? Must haves? Engineering or related fields, Experience in regulated industry (e.g. ISO 13485/5840) or with quality stds (eg. ISO), Analytical and detail-oriented
What are nice-to-have skills? Experience in surgical valve-related fields, Risk documentation development/maintenance, Understanding of statistical process
The main function of a quality engineer is to research and test the design, functionality and maintenance of products, equipment, systems and processes and develop quality standards. A typical quality engineer has the ability to read and interpret blueprints and evaluate product integrity and standards.
Education And Experience
- Bachelor’s degree in engineering required
- 2-4 years' experience required
- Relevant experience in product development, quality assurance, and/or related fields
- Knowledge and understanding of Engineering and Quality principles, theories, and concepts
- Understanding of ISO 13485
- Experience developing, updating, and maintaining technical content of risk management files
- Print reading skills
- Understanding of statistical techniques. Experience using statistical software (Minitab, JMP) a plus. CAD experience (Solidworks or- Creo) a plus
- Experience in test method development, including validation and/or fixture development
- Understanding of medical device operations and/or manufacturing processes
- Solid problem-solving, organizational, analytical and critical thinking skills
- Good documentation, communication (e.g., written and verbal) skills
- Ability to build productive working relationships and interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Designs devices sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
- Establishes a program to evaluate the precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.
- May write training material and conduct training sessions on quality control activities.
- May specialize in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, research and development, and administrative application.
Job #: 25-26897
