17192 Daimler Irvine, CA 92614 US
- This is an onsite position. Candidate needs to have flexibility to work weekends, work overtime as needed.
- Perform routine and non-routine testing services using established procedures/protocols (e.g. environmental & package integrity testing (40%)
- Perform data entry of routine and non-routine testing. Prepare data summaries, reports, and protocols using existing templates as a model (30%)
- Maintaining tests records and daily work logs.
- Do sample builds according to engineering directions and protocols.
- Propose and update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations (5%)
- Initiate and support test investigations and propose recommendations for manager view (5%)
- Assist in testing validation/revalidation activities for critical systems and equipment under close supervision (5%)
- Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on records (e.g device history records) (10%)
- Maintain equipment in proper working order and maintain a clean laboratory
SKILLS Top Skills:
- Strict attention to detail
- Good computer skills, including usage of MS Office Suite (Word, EXCEL and PowerPoint are key)
- Good written and verbal communication, interpersonal, and relationship building skills
- Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)
- Knowledge of and adherence to Client Environmental Health and Safety and Quality guidelines as they relate to lab and/or clean room medical device manufacturing preferred
- Understanding of equipment in a lab environment
- Fluent in English
- Must be able to work in a team environment, including inter-departmental teams
- Ability to perform more complex troubleshooting
- Ability to identify problems and relevant issues in straightforward and more complex situations, assessing using standard procedures
- Ability to use a wider range of manufacturing, test, development, or diagnostic equipment; use tools such measuring equipment
- Work collaboratively with outside vendors
- Ability to read and understand procedures, drawings, schematics and carry out assembly instructions
- Ability to provide feedback in a professional, direct, and tactful manner
- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
- Able to lift up to 20 lbs
- Understand statistic fundamentals and Design of experiments (its a plus)
- Ability to prioritize different tasks as needed.
- Associate degree or equivalent or technical degree/certificate, Bachelor's degree preferred, 4 years R&D Lab and/or medical device experience required, or 6 years related experience required
**salary will be commensurate with experience**
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.