Senior R&D Quality Engineer-- KAUDC

Senior R&D Quality Engineer (KAUDC
5698989)

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This range is provided by Compunnel Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$63.00/hr - $65.00/hr

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This role supports R&D and New Product Development (NPD) projects as part of the Design Assurance/Quality Engineering team. The Senior Engineer will partner closely with R&D, Operations, and Manufacturing to ensure product quality, patient safety, and regulatory compliance throughout the product lifecycle — from development through commercialization. Products are health-related and primarily polymer-based medical devices.

• Support two active projects:
• Project 1: manufacturing process qualifications and build support (commercialization phase).
• Project 2: early-phase new product development focused on design & development activities.
• Collaborate with R&D and Operations on design controls, verification/validation, test methods, and risk management.
• Lead and maintain risk management documentation (including FMEAs) aligned to ISO 14971
  .
• Investigate product and process quality issues; support root‑cause analysis using Six Sigma/DMAIC tools.
• Contribute to project plans, timelines, and documentation to support regulatory approvals.
• Support process validation, test method validation, and statistical analysis (Minitab preferred).
• Help ensure compliance with federal, local, and company quality system requirements.
• Mentor and collaborate with cross‑functional teams; coordinate activities with engineers/technicians.
• Balance daily work across ~60% desk / 40% manufacturing floor
  .

You will be guided by a Senior Principal Engineer overseeing both projects, with room to learn and ramp up.

• Experience qualifying products and processes in medical device manufacturing
  .
• Hands‑on Quality Engineering in regulated environments (preferably Class III devices).
• Experience across multiple phases of product development (concept → launch).
• Comfortable managing multiple projects at once.
• Familiarity with process validations and statistical tools (Minitab is a plus).
• Cleanroom exposure is helpful (not required).
• Strong analytical, problem‑solving, and communication skills.
• Ability to interpret drawings, schematics, and technical documentation.
• Knowledge of design controls, risk management, and verification/validation.
• Team‑oriented with attention to detail; ability to mentor and collaborate effectively.
• CAD or engineering software experience preferred.

• Bachelor’s degree (Engineering preferred, others considered with relevant experience).
• 3–10 years of engineering experience, ideally in Quality, R&D, or Product Development within medical devices.

Mid‑Senior level

Contract

Quality Assurance

Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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