System Designer

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500 employees globally, with over 30 locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Company: One of Our Clients

Job Description:

Job Title: System Designer

Location: Warsaw, IN 46580

Duration: 06 Months (Extendable)

Pay Rate: $45.00 – 50.00/hr on W2.

4 Openings

Job Description:

The ideal candidate will have a solid background in medical device design controls and product development, with direct experience in regulatory compliance and documentation. You’ll play a key role in refining existing documentation and ensuring continued regulatory alignment to support new and existing products.

Candidates must have experience with software as a medical device (SaMD).

Requirements

• 5 years of experience
• Strong Experience with Software as a Medical Device (SaMD)
• Strong experience in design controls in a multi-disciplinary organization.
• Experience drafting and maintaining DHF (design history file) content, including user needs, design inputs, design outputs, traceability matrices, and risk documentation.
• Able to support risk analysis (e.g. uFMEA, etc.) and contribute to usability planning and design mitigations.
• Familiarity with ISO 14971 is required, and IEC 62366 preferred.
• Ability to define testable requirements, support V&V protocol development, and ensure traceability in collaboration with the Product Development team.
• Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders.
• Must have experience in a regulatory environment with strict compliance.
• Strong analytical skills and accurate judgment-making skills.
• Ability to deal effectively with internal and external collaborators.
• Excellent communications skills; written and verbal.
• Experience with Codebeamer, Jira, or similar.

Duties and Responsibilities

System Design

• Define the design approach, ensuring alignment with product objectives, user needs, clinical workflows, and system performance.
• Translate user needs and system requirements into practical design solutions.
• Lead design discussions and technical reviews, evaluating alternatives and trade-offs.
• Ensure design decisions address usability, risk mitigation, technical feasibility, and long-term product sustainability.

System Testing

• Implement and review product verification and validation (V&V) testing, including developing protocols, test methods, and performance specifications.
• Perform manual and automated testing and document results accurately.

Product Documentation

• Collaborate with QA, Service, Compliance, and Regulatory teams to meet documentation requirements and ensure cross-functional alignment.
• Create, review, and maintain risk management files, including cybersecurity risks.
• Ensure all product requirements are documented, traceable to verifiable tests, and kept up-to-date.
• Ensure compliance with FDA, ISO, and internal design controls.
• Maintain the Design History File (DHF) to be complete, accurate, and regulatory-compliant, addressing gaps proactively.

Education:

Education Requirements

Bachelor’s degree in engineering or science related field; biomedical engineering preferred.

Awards and Accolades:

America's Most Honored Businesses (Top 10%)

Awarded by USPAAC for the Fastest Growing Business in the US

12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)

Fastest 50 by NJ Biz (2020, 2019, 2020)

INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)

Top 100 by Dallas Business Journal (2020 and 2019)

Proven Supplier of the Year by Workforce Logiq (2020 and 2019)

2019 Spirit of Alliance Award by Agile1

2018 Best of the Best Platinum Award by Agile1

2018 TechServe Alliance Excellence Awards Winner

2017 Best of the Best Gold Award by Agile1(Act1 Group)