Job Title: Software Quality Engineer For immediate consideration please apply to this posting and email your resume to **kacgonzales@actalentservices.com** Job Description We are seeking a highly skilled and motivated Software Quality Engineer to join our dynamic team. In this role, you will be responsible for ensuring the highest standards of software quality and compliance are achieved across multiple new product development projects. You will be part of the software core team and help oversee software development efforts from the early stages (concept/feasibility). Responsibilities + Ensure the highest standards of software quality and compliance are met for new product development projects. + Oversee software development efforts from early stages of concept and feasibility. + Conduct quality assurance, software validation, and quality engineering tasks. + Perform software quality assurance and root cause analysis for medical devices. + Test and validate software in compliance with medical device regulations and standards such as IEC, ISO, and FDA 21 CFR Part 820. + Engage in software testing, quality control, automation testing, and supplier quality management. + Manage and support the testing team, providing hands-on assistance with testing procedures. Essential Skills + 8+ years of experience in software quality assurance for Class II/III medical devices. + Bachelor's degree in computer science, computer engineering, or a related discipline. + In-depth knowledge of medical device regulations and standards, including IEC, ISO, and FDA 21 CFR Part 820. + Proficiency in quality assurance, software validation, and quality engineering. + Strong skills in root cause analysis, software testing, and quality control. Additional Skills & Qualifications + Familiarity with Python Automation Framework. + Knowledge of C++ and C#. + Experience with ADO. Work Environment You will be working within an open 'pit' environment, engaging hands-on within labs and testing various catheter-related devices. The team is currently small with 38 employees, but there are plans to expand to 50 by the end of the year. This is a great opportunity for personal growth, where you can enhance your management skills while contributing to a collaborative team. Pay and Benefits The pay range for this position is $70.00 - $90.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Irvine,CA. Application Deadline This position is anticipated to close on Feb 25, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.