Job Description

Job Title: Senior Advanced Quality Engineer

18+ month contract

On-site (Hybrid) in Tempe, AZ

Must be able to work on a W2

Job Description:

We are hiring a Senior Engineer, Advanced Quality to support our reprocessing product line. You will be a key member of the new product development team ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with industry practices. Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs team members, you will be in a fast-paced environment with opportunities to win for yourself, the company, and patients around the world. This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer.

Workplace Flexibility: Candidate must reside within a commutable distance to Tempe, AZ and is expected to be onsite 3+ days/week at the facility and is not eligible to be fully remote.

What you will do:

• Represents Quality Assurance on New Product Development (NPD) cross-functional teams, collaborating with R&D, Regulatory Affairs, Advanced Operations, and Marketing to meet product development metrics.
• Leads Risk Management activities, including creating and implementing Risk Management Files, identifying hazards, and ensuring compliance with corporate and divisional design control procedures.
• Plans, designs, and implements inspection, testing, and evaluation methods to ensure product and production reliability, applying advanced statistical techniques for test sample size determinations.
• Leads Design Reviews to ensure design and process robustness, compliance with applicable regulations (e.g., QSR, ISO 13485), and proper risk analysis for new medical devices.
• Plans, performs, and reviews engineering risk analyses, test methods, and process improvements to enhance product quality and manufacturing efficiency.
• Provides leadership in product development by guiding engineering principles, interpreting test data, and developing process and product protocols.
• Mentors junior staff, leads departmental initiatives, and influences multiple teams to drive quality and regulatory compliance throughout the development process.
• May interact with customers to address product quality concerns, provide training on quality assurance and GMP topics, and support continuous improvement initiatives.

What you will need:

Required:

• Bachelor's degree in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering.
• Minimum of 2+ years’ experience in an engineering role.
• Experience in data collection, data analysis, and scientific method.

Preferred:

• Experience with Quality Concepts such as Risk Management, CAPA, Audits, Statistics.
• Previous medical device industry experience preferred
• Understanding of US and International Medical Device Regulations, including ISO 13485, GDP, GMP.
• Six Sigma Green Belt or ASQ CQE.

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