Job Description

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Sr. Systems Engineer for a 14 month + Contract . Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

Work with the engineering team to solidify a new implant and instrument design control and risk management structure, based on a systems engineering approach. Develop architecture documents and use cases to help establish tiering of requirements as well as trace matrixes for design verification and validation.

Help with scoping of the JR implant and instrument portfolio and translation from legacy design controls to this new structure.

Implement this structure to work within the Jama requirements software system.

Position Description (Principle Duties and Responsibilities)

Technical Responsibilities:

• Research, design, develop, modify, and verify medical device systems.
• Translate user needs to system requirements.
• Modify existing system architectures or test designs.
• Create new system architectures or test designs for simple product or features.
• Contribute to design decomposition using, modeling, simulation, budgeting, or mathematical techniques.
• Apply fundamental and some advanced concepts, practices and procedures for problem solving.
• Contribute to Product Risk Management activities.
• Develop system architecture for joint replacement instrumentation design controls and risk management.
• Translate legacy requirements to new requirements in order to facilitate a systems approach and consolidated design controls and risk management.

Business Responsibilities:

• Demonstrate advanced understanding of customer needs and design inputs.
• Demonstrate proficiency with product's intended use and clinical procedures.
• Learn how the financial models are constructed.

Med Device Compliance:

• Follow fundamental industry standards, design requirements and test strategies which apply to regulatory requirements.
• Independently create or refine engineering documentation, such as the Design History file.
• Follow R&D procedure like design controls and risk management, per the Quality Management System.

General Responsibilities:

• Under minimal supervision, work with all stakeholders to ensure project success.
• Quickly process and assimilate procedures, policies, processes, systems, and technology required.
• Work on complex problems, applying advanced experience and learnings.
• Demonstrate ownership and prioritize work with minimal supervision.
• Works as key member of the team, collaborating with others and solidifying relationships.

Qualifications

• Bachelor of Science in Software, Electrical, Mechanical, Systems, or Biomedical Engineering & 2+ years of work experience.

Technical Skills:

• Working knowledge and understanding of requirement and verification practices.
• Working knowledge of Requirements Management Tools.
• Ability to communicate basic plans and technical information to team members.

Preferred Skills / Engineering tools:

• Requirements Management Software, especially Jama.
• Experience with SysML and Model-based Systems Engineering.
• Experience with SysML / MBSE software tools.
• Knowledge of ISO 13485 and ISO 14971.

Certifications:

INCOSE ASEP certified, or equivalent

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