R&D/QA Technician/Technologist

TalentBurst; Irvine (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in medical devices is seeking an R&D/QA Technician/Technologist for a contract role in Irvine, CA. The ideal candidate will have a strong background in testing heart valves, electrical and mechanical skills, and experience with lab equipment. You will perform critical testing and analysis while contributing to product development for complex systems. This role requires proficiency in ISO standards and effective communication skills, with opportunities for learning in a collaborative environment.

Qualifications

• 4 years experience in an R&D lab or 6 years of related experience.
• Strong understanding of ISO standards.
• Ability to perform complex troubleshooting.

Responsibilities

• Perform testing and equipment maintenance (65% time).
• Operate lab equipment and validate test methods (20% time).
• Train and guide lower-level employees (5% time).

Skills

Good communication

Electrical skills

Mechanical skills

Adaptability

Education

Associate's degree or technical degree/certificate

Tools

MTS tensile testers

X-Ray equipment

SEMs

CAD software

Job description

Position: R&D/QA Technician/Technologist , Req#: 11128 -1
Location: Irvine, CA (100% Onsite)
Duration: 7+ Months Contract

Schedule: Work is on site, 5 days a week, Monday-Friday. Typical shift is 8:30-4:30 or 9-5:30. Rarely any overtime unless needed.

Job Description:

What does your group do? My group is a group of techs that perform various testing for new product development teams and manage the operations and equipment of the Surgical R&D Lab.. Specifically we perform testing on heart valves and accessories per ISO standards for design verification and feasibility studies.

Does your team use any specific technology/software you want us to look out for? MTS tensile testers (or instrons), X-Ray, SEMs (scanning electron microscope), Fatigue testing, accelerated wear testing AWT, and hydrodynamic testing, 3D printing

What would stand out to you in a resume?
Good verbal and written communication
Experience using various types of equipment and managing them ( pm, calibrations, etc)
Strong expertise in electrical and mechanical skills!! (Preferred)
Has experience with the above equipment listed under question 2

What does the ideal candidate need to possess to be successful in this role?
Good communication skills
Flexible, adaptable, fast-paced
Willingness to learn
Good with computers and software
Electrical and mechanical skills
Can work in a diverse team (my specific team is 7 people but we work with various types of people)
Previous medical device experience
Has executed IQs/validations
Mentions of ISO standards

What will a typical workday look like? The expectation after proper training would be independence. The employee will come in and work on the project they are assigned. We work with surgical heart valves and accessories, so it'll be some form of testing for valves or accessories for the valve. For example, a project can involve fixing a valve, taking images of it, performing hydrodynamic testing, and then a long-term project on an accelerated wear tester. You'll also be expected to manage assets in the lab.

What will the work schedule be? Can any overtime be expected? W ork is on site, 5 days a week, Monday-Friday. Typical shift is 8:30-4:30 or 9-5:30. Rarely any overtime unless needed.

What specific product would this person be working on? The first device is a Client highly complex (> 50 parts) system inclusive of a delivery system and a permanent implant. They need to be able to apply the first principles of engineering and understand how material properties impact stress and strain response, they have to understand tolerance stack-up and how to design for anticipated production variance.

What are your top 3 required technical skills? Must-haves?

Good communication (can speak well, is understandable)
Electrical and mechanical skills
Quick learner and good with technology

What are nice-to-have skills? SEM, fatigue testing, hydrodynamic testing, previous medical device experience

Role Purpose
Performs a wide variety of tasks in support of Engineering activities.

Education and Experience:

• Associate's degree or equivalent or technical degree/certificate with 4 years of previous experience in R&D Lab and/or medical device experience required, OR
• 6 Years of 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 as 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 the client's 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 the 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 the environment and prevention of pollution under their span of influence/control

Job Responsibilities:

• 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 troubleshooting 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 tests 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 photocopying or deliveries) - 5%

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