Systems Integration Engineer

Systems Integration Engineer Seeking an Engineer who will be responsible for leading medical device projects by managing cross-functional engineering teams in alignment with established design control requirements and practices. Responsibilities Coordinate subject matter experts to resolve issues during development, verification / validation, and production phases. Ensure adherence to medical device design control standards throughout all design phases. Establish and maintain program and product Design History Files. Lead Technical Design Review meetings to document and resolve technical issues, and conduct Phase / Gate Design Reviews to track progress through the design control process. Develop comprehensive program plans that outline objectives, identify risks and mitigation strategies, estimate required effort, and set development timelines. Collaborate with core team members to address and mitigate risks. Escalate unresolved risks through appropriate internal channels. Facilitate core team meetings, distribute agendas and meeting minutes, and monitor progress against schedules, deliverables, regulatory requirements, and action items. Resolve conflicts within and outside the team environment. Estimate project effort and resource needs, collaborating with team members to define project scope. Prepare detailed project plans, schedules, and budgets using tools such as Microsoft Project. Manage project assignments, initiate and maintain project schedules and milestones. Follow the Product Life-Cycle Management process to ensure complete and well-documented Design History Files. Qualifications Bachelor’s degree in engineering, project / program management, or a related discipline. 3+ years of experience in medical device project management or a related role. Proficient in Microsoft Office Suite and similar tools. Capable of managing multiple priorities simultaneously. Demonstrated success in leading cross-functional teams and fostering collaboration. Skilled in team mediation, encouraging open discussion and consensus-building. Ability to influence and guide team members without direct authority. Builds and maintains productive relationships with internal stakeholders. Actively listens to customer input and incorporates feedback into decision-making. Inspires and motivates teams to achieve project goals on time. Fosters team accountability and cultivates a results-oriented culture. Adapts effectively to change and uncertainty while maintaining regulatory compliance. Makes informed, timely decisions in dynamic environments. Familiarity with regulatory requirements including FDA and EU MDR compliance. PMP certification is a plus. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, age or veteran status.