Validation Engineer

Date Posted: 07/24/2024

Hiring Organization: Rose International

Position Number: 468052

Job Title: Validation Engineer

Job Location: Round Lake, IL, USA, 60073

Work Model: Onsite

Employment Type: Temporary

Estimated Duration (In months): 6

Min Hourly Rate($): 40.00

Max Hourly Rate($): 40.00

Must Have Skills/Attributes: FDA, Medical device, Validation

Job Description

***Only qualified Software Validation Engineer candidates located near the Round Lake, IL area to be considered due to the position requiring a 100% onsite presence***

Education and/or Experience:

• Bachelor’s (B.E/B. Tech in Computer Science / Electronics & Communication / Electrical)

• Strong communication skills – written & verbal

• 2-6 years of relevant technical experience in Validation & Verification, System Integration, defining systems and requirements for medical products

• Prior experience in Medication Delivery device domain, Medical Design experience with Infusion Pumps and Syringe Pumps is a plus

• Strong interpersonal skills with ability to work in a collaborative environment as well as independently with minimal supervision

Qualifications & Skills:

• Hands on experience on Safety standards (IEC 60601 series) including collateral and particular standards

• Familiarity with regulatory requirements of FDA and EU MDR

• Strong team player, able to meet deadlines and handle changing priorities

• Experience in resolving complex technical problems using strong analytical skills

• Excellent written, oral and interpersonal skills

• Must be proficient at time management and multitasking

Our client is seeking a qualified Software Engineer with hands on experience in Verification & Validation, System Integration, Connectivity and Design of Medical Devices. Candidate should have good understanding of connectivity technologies wired and wireless.

Software (Validation) Engineer Responsibilities:

• Develop test plans, test protocols, and test reports for Platform/System Level testing

• Perform the end to end and integration testing of Medical Devices

• Develop and maintain an effective and corroborative working relationship with internal and external development partners

• Interact with clinical and marketing to develop and refine user requirements

• Ensure user needs are captured, quality requirements are met and technical risks are mitigated from Interoperability side

• Manage integration of deliverables from sub-system design teams and external partners

• Plan and execute system integration activities to minimize issues in systems validation

• Document traceability from requirements to verification activities for Interoperability Reports

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Benefits:

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).