"Alerted.org

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 [email protected].

_*** (Kelly does not expense relocation/interview costs)**_

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.