R&D Test Engineer

Pentangle Tech Services | P5 Group; Irvine (CA); On-site; USD 85,000 - 125,000; Full time

Job summary

Pentangle Tech Services | P5 Group in Irvine, CA is seeking a qualified engineer to assist in developing innovative drug delivery products and to establish verification strategies across plans, protocols, and records.

You will lead test procedures, analyze data, document results, and present to cross-functional teams while ensuring compliance with regulatory and safety requirements.

Responsibilities

• Assist in the development of innovative drug delivery products.

Skills

Verification strategies

Root cause investigations

Test procedures

Data analysis

Documentation

Cross-functional collaboration

Independent work

Problem-solving

Quality compliance

Tools

Zwick/Instron

3D printing

Viscometers

Climate chambers

MS Project

LIMS LinkUS

DOORS

Cockpit

SolidWorks

Minitab

ELN

Job description

• Assist in the development of innovative products for drug delivery to patients.
• Define, lead, and execute verification strategies, including creating verification plans, protocols, records, and reports.
• Determine sample size strategy based on scientific rationale conforming to internal and regulatory guidelines.
• Lead and execute test procedures, write protocols supporting engineering and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams.
• Lead root cause investigations and issue resolutions.
• Define, develop, and validate test methods.
• Recommend improvements in design, processes, and execution of projects or tasks, as well as program maintenance.
• Comply with applicable policies, procedures, regulatory, and safety requirements.
• Review and evaluate design changes for compliance and technical competencies.
• Perform technical duties according to quality and functional standards.
• Conduct tests to determine physical and mechanical characteristics of materials for quality control, process control, or product development.
• Experience with Zwick (or Instron) and flow measurement equipment is preferred. Familiarity with 3D printing, viscometers, climate chambers, etc., is a plus.
• Familiarity with Microsoft Project and Laboratory Information Management System tools such as LinkUS, Requirement/Risk Management tools such as DOORS, or Cockpit is desired.
• Experience with engineering tools such as SolidWorks, Minitab, and Electronic Lab Notebook (ELN) is a plus.
• Demonstrated problem-solving skills and fundamental technical depth are essential.
• Work independently under the guidance of a supervisor or technical lead. Assignments have clear and specified objectives.