Principal Engineer, Software Engineering

Overview

On Site
USD 55.00 - 63.00 per hour
Contract - Independent

Skills

Software Engineering
Research Design
Medical Devices
System Requirements
Conflict Resolution
Problem Solving
Systems Architecture
Instrumentation
Finance
Regulatory Compliance
Research and Development
Quality Management
Supervision
Requirements Management
SysML
ISO 13485
ISO 9000
Science
Electrical Engineering
Mechanical Engineering
Biomedical Engineering
Software Development
Debugging
Technical Drafting
Functional Requirements
Systems Analysis/design
Documentation
Risk Management
Use Cases
Verification And Validation
Translation
Design Controls
Jama
Systems Engineering
Modeling
Budget
Privacy
Marketing

Job Details

Location: Mahwah, NJ
Salary: $55.00 USD Hourly - $63.00 USD Hourly
Description: Our client is currently seeking a Principal Software Engineer for a 12 month + contract.

KEY AREAS OF RESPONSIBILITY: What you will do:

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.

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.

PREFERRED QUALIFICATIONS: What you will need (strongly desired):

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.

POSITION 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 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.

system engineering techniques such as: traceability, architecture, modeling, trade studies, simulation, and budgeting. Systems Engineers are also responsible for ensuring the systems gets integrated and may lead the Verification effort.

MINIMUM QUALIFICATIONS: What you will need (must have):

EDUCATION REQUIREMENTS

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

Follows company software development lifecycle to design, code, configure, test, debug, and document system and application programs.

Assists in preparing technical design specifications based on functional requirements and analysis documents.

Reviews functional requirements, analysis and design documents and provides feedback.

Collaborates with other development staff to achieve quality and consistency.

Participates in architecture, design and code reviews.

Develops and maintains operational and system level documentation.

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. system engineering techniques such as: traceability, architecture, modeling, trade studies, simulation, and budgeting.

Systems Engineers are also responsible for ensuring the systems gets integrated and may lead the Verification effort.

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Contact:

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