Thermal Engineer III – Product Development
EPTA GROUP
Senior Engineer I – QA Design
Artex Risk Solutions
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $109,250 - $156,687 per year
Job Level
Senior
About the role
- Responsible for Quality Assurance functions and design development activities of Class I and II medical devices in compliance with FDA, ISO, CMDR Quality Systems and Design Control requirements.
- Lead design assurance efforts within product design and development for new product introduction projects with emphasis on software, electrical, and/or mechanical device characteristics.
- For electrical/active device projects, lead compliance for electrical safety, environmental, and emissions per national and international regulations.
- Ensure appropriateness of documented design requirements and outputs and maintain traceability throughout product development lifecycle.
- Provide leadership implementing regulations/standards and act as resource to other disciplines from idealization through product retirement.
- Supervise, assign, and coordinate work of others within the design assurance team to support department and project goals.
- Lead lessons learned initiatives to improve design processes and the quality management system.
- Lead product risk assessment activities using ISO14971, FMEAs, FTA, and Hazard Assessment.
- Provide guidance on usability/human factors engineering principles (IEC 62366) and FDA guidance for compliance.
- Facilitate planning, execution, and review of verification/validation activities including assessment of inputs to the v&v process.
- Lead design assurance aspects of Design to Manufacture Transfer, including inspection methods, drawing reviews, KPIs, and manufacturing training.
- Ensure required outputs of design control are met, maintain Design History File (DHF), and support transition to sustaining engineering.
- Support design-related corrective and preventative activities and establish/maintain Risk Management File(s).
Requirements
- Bachelor’s degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering preferred.
- 5 years design assurance/quality assurance experience in a medical device or other highly regulated industry required.
- Working knowledge of ISO and FDA design and development quality requirements.
- Technical knowledge in development methodologies, design quality analysis, and project implementation.
- Proficiency in assessing manufacturing quality requirements of new product concepts.
- Technical knowledge in development methodologies, design, and project implementation, including GD&T & DOE preferred.
- Experience in DHF & Technical File structure and maintenance.
- Basic knowledge in Electro-Medical safety standards (IEC 60601-1, IEC 60601-1-2) and other Collateral and Particular standards.
- Hands-on experience and knowledge in global medical device regulatory requirements for Electro-Surgical Devices.
- Essential knowledge of Risk Management for medical devices (per ISO 14971).
- Proficiency with PC operations and the Microsoft Office suite; hands-on experience with Minitab, SAP, Codebeamer and Windchill preferred.
- Strong reasoning ability, verbal and written communication skills.
