R&D Lab Specialist

R&D Lab Specialist

Kelly Engineering is seeking an R&D Lab Specialist for a long-term contract with one of our Global Medical Device clients located in Irvine, CA. Our Client is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide.

As a Kelly employee, you will be eligible for Medical & Dental 50% paid, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time. All Kelly OCG employees receive annual performance reviews. The individual will be responsible for supporting a multi-systems lab at a medical device company.

Qualifications:

• Needs good organization and computer skills in Excel and PowerPoint, read and review documents, very accurate and assertive professional
• HS diploma required, AS or BS degree preferred but not required
• Excellent Excel and PowerPoint skills
• Medical device industry a plus
• Analytical, report-driven, very well organized and quality driven
• Lab experience
• Excellent team player, gets along well with everyone, easy-going with a friendly attitude
• Communicates business-related issues and/or opportunities to the next management level or supervisor
• Will need to learn PLM system

Lab Assistant for an R&D Combined Lab Multi-Systems Lab, Tissue lab, Systems Integration Lab, Instron Lab, R&D Supplies Rm, Bio-simulator Lab, R&D Storage

Manage Lab Space

• Assist in planning, coordinating, and directing lab activities
• Manage floor, side labs, and common test/equipment areas.
• Maintain laboratory general maintenance and upkeep of facility.
• Evaluate project team areas and requirements per request.
• Facilitate lab and workspace organization.
• Provide support /resolves to Project teams and cross-functional teams for space needs/testing, as necessary
• Oversee testing setups within the lab (non-V&V only)
• Provide and collaborate with EHS (Environment Health and Safety) for materials, equipment, and movement within space.

Equipment management

• Lab Equipment maintenance.
• Meet and collaborate with CRM (Calibration, Repair & Maintenance) personnel
• Communications and interactions with a calibration service provider.

Maintain a Combined Lab Equipment Master list, including:

• Project team equipment.
• Control of loaner equipment
• General lab equipment.

NCs (non-conformity )

• NC delegation and support for lab.
• ETQ training.
• Guidance with forms (Calibrations, Late Cal, Relocate, Inactivate/Reactivate, Preventive Maintenance, etc.).
• Equipment improvements for common lab use.
• Communicate with suppliers.
• Follow up and resolve any challenges with procured equipment/machine, if any.
• Coordinate, plan, and direct resources to move and install equipment/machine.
• Look for strategic changes/needs for new capabilities/equipment (Need to move to newer technologies with R&D to transition to longer-term manufacturing) Ex. Wire strippers, ovens, etc.

General lab improvement

• Posted signage, promoting 6S organization, and exercising risk management.
• Continuous improvements of spaces, utilities, repairs, etc.

3D printer Management (oversee)

• Teams – BWI R&D Prototype Lab: 3D Print Channel with Excel spreadsheet. tracker (Date, Username, Email, Project, Resin type and Volume, Duration).
• Restock 99% IPA (Isopropyl Alcohol) as needed.
• Hold users accountable to maintain area cleanliness, and maintain resin in stock, consumables readily available by completing tracker.

Facilities request

• Submit facilities request as needed
• Track/ Follow up on facilities requests for
• Repairs
• Installations.
• IT (Information Technology) tickets/requests (IRIS) if needed.

Lab safety walkthroughs

• Perform weekly
• Align with EHS procedures.
• Perform and submit EHS Lab inspections Tracked by EHS – Quarterly.
• Support On-site Audits
• Maintain organized and compliant.
• Communications to R&D Reminders and refresher.

Chemical Inventory Management

• Provide support with EHS new chemical approval forms. Only store chemicals that are approved and listed on 3E for the lab.
• Proper labeling of all chemicals and secondary containers/vessels with liquids, solids, etc., all need to be identifiable.
• HMIS labels with chemical expiration date.
• Replace non-legible labels.
• Inventory of general IPA, flux, resins, etc., to maintain stock and availability.
• All chemicals/biohazard/e-waste to be disposed of by Viola (Hazardous waste service).

Lab Supplies Management

• Inventory control of common lab supplies from stockroom (PPE, chemicals, soaps, wipes, general lab consumables).
• Procure additional supplies via McMaster-Carr, PAC
• Schedule DI water tank service (Monthly).

Systems and Metrology Room

• Instron Machines
• Manage Instron calendar and assist engineers with test setups.
• Control of tools, accessories, and load cells required for testing.
• Repairs/Replacements- assessment, schedule and/or send out for repair or replacement (request quote, PO creation).
• Keyence manages and schedules any repairs.
• Coordinate/Schedule any…