Software Quality Engineer I (MedTech)

TL;DR

Software Quality Engineer I (MedTech): Supporting Released Product Engineering for Acute Care & Monitoring, focusing on development, improvement, and innovation through technical excellence and cross-functional collaboration. Focus on applying design controls, risk management, and change control processes in the evaluation and release of product changes.

Location: Lafayette, Colorado, United States of America

Salary: $64,800.00 - $97,200.00

Company

hirify.global is a global healthcare technology leader that addresses challenging health problems.

What you will do

• Critically review new and modified product and software changes to determine their impact on existing requirements, patient safety, standards compliance, and reliability.
• Ensure that design changes to existing products comply with hirify.global’s QMS, ISO13485, EU-MDR, and FDA Quality System Regulations.
• Lead cross-functional teams to develop product risk management files (risk management plan, risk assessments, dFMEA, and risk management report).
• Assist in the creation of verification and validation test plans, protocols, and reports; review testing and analysis for standards and product requirements compliance.
• Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.

Requirements

• Requires a Baccalaureate degree and 0 years relevant experience.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• Must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, Dental and vision insurance.
• 401(k) plan plus employer contribution and match.
• Paid time off and paid holidays.