Senior Engineer I – QA Design

Job not on LinkedIn

September 3

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $109.3k - $156.7k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Artex Risk Solutions

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Finance • Insurance • Risk Management

Artex Risk Solutions is a leader in alternative risk management, providing innovative solutions for both large and small organizations. They specialize in creative risk management strategies that help clients optimize their cost of risk, leveraging expertise in capital solutions, specialty risk transfer, and carrier outsourcing services. With a global presence and a commitment to challenging traditional approaches, Artex aims to empower businesses to make informed risk management decisions and enhance their operational efficiency.

501 - 1000 employees

Founded 1997

💸 Finance

📋 Description

• 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.

🏖️ Benefits

• Medical, Dental and Vision Insurance • Company-Provided Life Insurance • Voluntary Life Insurance • Flexible Spending Account (FSA) • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) • Matching 401(k) Retirement Plan • Annual Bonus • Wellness Incentive Program • Free Onsite Lunch • Gym Reimbursement Program • Tuition Reimbursement Program • Trip of a Lifetime • Paid Parental Leave • Paid Time Off • Paid Sick Leave • Volunteer PTO • Employee Assistance Provider (EAP)