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 intellectual property.

QUALIFICATIONS

Education:

• Bachelor's degree in Computer Science or an Engineering discipline.
• Master's Degree in Engineering is a plus.

Experience & Skills:

• 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.

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.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

• While performing the duties of this job, the employee routinely is required to sit; walk; talk; hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, and stretch.
• The employee is occasionally required to move around the facility.
• The employee may occasionally lift and/or move up to 20 pounds.
• May require travel dependent on business needs (less than 10% travel on average).
• Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• The environment generally is moderate in temperature and noise level.
• Must be able to read and interpret data, information, and documents.
• Can observe and respond to people and situations and interact with others encountered in the course of work.
• Can learn and apply new information or skills.