Systems Design Engineer (Design Control)
Contract Duration: 14 months - Estimated to end: 2/2027 (Contract extension possibilities)
Location : Mahwah, New Jersey (07430) - Hybrid or Remote
Type : W2 contract (NO C2C OR THIRD PARTY)
Work Authorization: Must be currently in the United States with active employment authorization documents without CURRENT sponsorship transfer requirements. Sponsorship is not available now or in the future for this role.
Pay: Negotiable depending on direct-related experience up to $48 - $53 an hour
Job Summary:
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 implant and instrument portfolio and translation from legacy design controls to this new structure.
Implement this structure to work within the requirements software system.
Strongly Desired Qualifications:
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.
KEY AREAS OF RESPONSIBILITY:
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.
Technical Responsibilities: (Under minimal supervision):
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.
Must Have:
Bachelor of Science in Software, Electrical, Mechanical, Systems, or Biomedical Engineering & 2+ years of work experience.
Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.
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(Kelly does not expense relocation/interview costs)****
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