Job Title: Software Quality Engineer Location: Onsite Hours: 40 hours per week Overview: We are seeking a dedicated and detail-oriented Software Quality Engineer to join our Stealth Station in the Navigation business unit. In this role, you will work closely with cross-functional team members to support post-market software-related activities, ensuring our cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices. Key Responsibilities: + Requirements Analysis and Management: Evaluate product definition requirements to ensure they are clear, complete, testable, and assess test coverage. + Software Documentation and Specification: Review and remediate design output documentation, ensuring they meet intended use and performance criteria. + Quality Assurance and Compliance: Follow Quality System Practices and meet FDA, ISO, and European Medical Device standards and regulations, identifying design-related gaps and implementing mitigation strategies. Responsibilities Include: + Support product quality by conducting evaluations of software systems activities, including requirements, design, development, documentation, integration, test verification, and validation. + Ensure projects and process control documentation comply with requirements, objectives, and/or contracts. + Review software systems design change specifications and plans against process requirements. + Collaborate with test engineering on verification and validation strategies, reviewing and approving test protocols and reports. + Support the post-market release lifecycle, including remediation, CAPA, and other assigned activities. Qualifications: + Bachelor's Degree in Engineering, Science, or a technical field with 2 years of work experience in Engineering and/or Quality OR an Advanced Degree in Engineering, Science, or a technical field with 0 years of work experience in Engineering and/or Quality. + Proficient in requirements analysis and management, software documentation and specification, and quality assurance and compliance. Preferred Qualifications: + Experience in the medical device industry. + Familiarity with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards. + Navigation systems experience. + Excellent oral and written communication skills. Interview Timeline: We are looking to schedule interviews as soon as possible. Join Us: Take this opportunity to contribute to the future of medical technology and ensure the highest standards of quality and safety for our products. Pay and Benefits The pay range for this position is $38.00 - $45.00 • 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 Lafayette,CO. Application Deadline This position will be accepting applications until Jan 13, 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.