Job#: 2066655 Job Description: Apex Systems is currently seeking a Design Quality Software Engineer for one of our top Medical Device clients in Maple Grove, MN. Please see below for details about this exciting growth opportunity and apply now! About the role: We have an exciting opportunity for a software focused Design Quality Engineer supporting a cross-functional team on development and maintenance of capital equipment firmware and software within the Interventional Cardiology (IC) division. This position will support a significant product development project with high visibility which will provide the right candidate with excellent growth potential and product development experience. This role will apply the directives of design controls supporting the software development lifecycle (SDLC), software verification and validation (V&V), risk management, product development, and regulatory and standards compliance. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Your responsibilities include: Participates in the implementation of new product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V, Applies software application development procedures and provides support to demonstrate compliance through technical documentation generation. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. software bugs). Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization. Update and maintain software risk management tools (i.e. Hazard Analysis, FMEAs). Participate in Cybersecurity related discussions and assist supporting activities Assist in the design and development of software test methods and inspection procedures. Support regulatory submissions to notified bodies. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. What we re looking for: Required Qualifications Bachelor s degree in engineering, or related discipline related field of study A minimum of 5 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience Understanding of Software Development Life Cycle (SDLC) Experience with software testing and issue investigation/resolution Experience with Issue Tracking Tools (JIRA) and requirements / test management tools Understanding of software configuration management (version control, Microsoft office tools) Adaptable and effective collaborator in a team environment and in self-directed work Strong communication skills (verbal & written) Ability to work in a highly matrixed and geographically diverse business environment Demonstrated use of Quality tools/methodologies Preferred qualifications Prior Software Design Assurance experience Medical device or other regulated industry experience Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304) Experience in conducting and participating in code reviews EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will con ider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. https://www.eeoc.gov/eeo-policy-statement