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R&D/QA Engineer Tech
17211 Red Hill Avenue Irvine, CA 92614 US
Job Description
*Depending on experience
Role Purpose
Performs a wide variety of tasks in support of Engineering activities.
Job Functions
Essential Job Functions
• Support a wide range of engineering activities such as test, check-out, modification, fabrication and assembly; may formulate and propose technical solutions. Perform complex work using drawings, diagrams, written and verbal instructions, layouts or defined plans to perform testing, checkout, and trouble-shooting functions. Responsible for equipment maintenance (e.g, PM, calibration and services). - 65% of time
• Operate a wide range of lab equipment including set-up, clean-up, break-down, and re-assembly. Collect, document, and analyze test data. Perform operational test and identify failure modes on systems and equipment and propose technical solutions. Perform test method validation for equipment and product designs - 20% of time
• Train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback to engineers on procedures - 5% of time
• May build prototypes and prepare feasibility test units, samples, and/or chemical solutions. May design and build simple fixtures; using sketches, CAD, etc. May create and modify drawings and procedures for fixtures, equipment, products, or processes. May initiate ECRs (Engineering Change Request). - 5% of time
Marginal Job Functions
• Other incidental duties (e.g. occasional photo copying or deliveries) - 5%
Qualifications
Education/Experience
• Associate's Degree or equivalent or technical degree/certificate with 4 years previous experience in R&D Lab and/or medical device experience required, OR
• 6 Years related experience required
Required Skills
• Strong written and verbal communication, interpersonal, and relationship building skills
• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)
• Strong computer skills, including usage of MS Office Suite; and CAD if applicable
• Full understanding of equipment in a lab environment
• Ability to perform complex troubleshooting
• Ability to identify problems and relevant issues in complex situations, assessing using standard procedures
• Ability to use a wider range of manufacturing, test, development or diagnostic equipment; use tools such measuring equipment
• Ability to read and understand procedures, drawings, schematics and carry out assembly instructions
• Knowledge and understanding of statistical techniques and procedures
• Ability to utilize CAD/drafting software (if applicable)
• Knowledge and understanding of ECR software systems (if applicable)
• Ability to draft technical documents (i.e, manufacturing and testing procedures)
• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to lab and/or clean room medical device manufacturing
• Strict attention to detail
• Must be able to work in an inter-departmental team environment, as well as with colleagues from other departments and represent organization to outside contacts, i.e., vendors
• Ability to provide feedback in a professional, direct, and tactful manner
• 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 environment and prevention of pollution under their span of influence/control
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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