Description:

　　SUMMARY: Primarily responsible for developing electro-mechanical systems and system architecture and its associated documentation per established quality system procedures. You will work with multi-disciplinary teams to meet product and project requirements, collaborating with engineers from a variety of companies and industries. DUTIES AND RESPONSIBILITIES: • Responsible for creating and building internal requirement sets and assisting the customer in developing user requirements, when needed. • Support developing the risk management plan and report. • Assist in creation, review, and documentation of risk analyses. • May assist development of a Hazard Analysis. • Accountable for ensuring product verification and validation and ensuring traceability is met for all requirements. • Coordinate and facilitate interdisciplinary technical discussions within project teams. • Responsible for coordinating and documenting system level analysis including system modeling, algorithm development, simulations, and system architecture. • Serve as the primary technical contact for customers on projects. • Accountable for the technical project scope and effort. • Participate in the efforts to identify and implement technology re-use. • Perform and participate in technical design reviews during product realization. • Assist in evaluating technical talent. • Identify technical training and tools for the systems engineering team. • Participate in the identification and protection of Nextern intellectual property. QUALIFICATIONS: • Bachelor's degree in Computer Science or an Engineering discipline. • Master’s Degree in Engineering is a plus. • Five or more years of experience, preferable in the medical device field, in the discipline of systems engineering. • Experience with system designs compliant with IEC 60601, ISO 13485, ISO/EN 14971, and IEC 62304 standards. • Experience with requirements management tools is a plus. • Experience with modeling tools (Matlab, Simulink, etc.) is a plus. • Knowledge of FDA 510(k), PMA, and De Novo pre-market submission processes is a plus. • Experience developing Class II and III medical devices is a plus.

　　Skills:

　　Systems engineering, Design Services, Hardware/Software, Electro-Mechanical, Customer Interaction, Full Lifecycle, Medical Device, Design, Electrical, Electrical engineering, software development

　　Top Skills Details:

　　Systems engineering,Design Services,Hardware/Software,Electro-Mechanical,Customer Interaction,Full Lifecycle,Medical Device

　　Additional Skills & Qualifications:

　　COMPETENCIES: • Analytical--Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. • Design--Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail. • Project Management—Participate in the development of project plans; Participate in the coordination of projects; Communicates changes and progress; Assist in the completion of project team activities. • Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things. • Teamwork--Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. • Change Management—Participate in the development of implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance. • Diversity--Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Promotes a harassment-free environment. • Ethics--Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

　　Experience Level:

　　Expert Level

　　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

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.