FLSA Status - Exempt Position Summary * Provide quality support and assurance for ICU Medical software development. The Software Quality Engineer will be responsible for software development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards, such as FDA QSR and IEC 62304. *Essential Duties & Responsibilities •Ensure the safety of the software products developed by managing the software product life cycle activities to meet the quality system requirements. •Ensure compliance, alignment and consistency with ICU Medical’s quality system and software development practices. •Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections. •Perform periodic audits of projects against SOP’s and process. •Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, code review, and unit test inspections. •Review, approve and participate in qualification of acquired software and software tools. •Review and approve resolution of released software issues. •Support regulatory submissions •Perform and support software risk analysis and management •Support software issue investigations, risk assessments and associated CAPA activities •Work special projects as assigned Knowledge & Skills •Expert quality compliance, audit, and investigation skills •Advanced software quality experience working in an Agile development environment. •In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.) •Up to speed on Cybersecurity changes and working knowledge of scoring vulnerabilities •Strong knowledge of medical device standards, including but not limited to: •ISO 13485 •IEC 62304 •ISO 14971 •In depth experience with and knowledge of FDA, MDR, and other key medical device regulations •Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables) •Proven ability to work closely with engineering teams and members of a cross functional team •New product software development experience is strongly preferred. •Cloud development experience is strongly preferred. Minimum Qualifications, Education & Experience * •Must be at least 18 years of age •Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required. •Minimum of 7 years of experience in software quality engineering, product design or product engineering in the medical device industry •ASQ CQE or CSQE required or the ability to obtain within one year. *Work Environment •This is largely a sedentary role. •This job operates in a professional office environment and routinely uses standard office equipment. •Typically requires travel 5% to 10% of the time Salary range: $96K-$129K The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location. ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Title: Senior Engineer, Software Quality Location: CA-San Diego Requisition ID: 24300365