Science,Science|Scientific Validator,Engineering Jobs

Job Summary:

• We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products.
• The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements.
• Experience with infusion pump systems or similar electromechanical medical devices is preferred.

Roles & Responsibilities:

• Plan and execute system-level Verification & Validation (V&V) activities for medical device products.
• Develop, review, and execute validation protocols, test plans, and test reports.
• Perform validation testing, document results, investigate failures, and support issue resolution.
• Ensure validation activities comply with applicable quality standards, regulatory requirements, and internal procedures.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Systems Engineering.
• Support design verification, risk management, and product validation efforts.
• Maintain accurate documentation in accordance with FDA, ISO 13485, and company quality system requirements.
• Participate in design reviews and provide technical input related to system validation.

Education & Experience:

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 10 years of Validation Engineering experience.
• Strong experience in the Medical Device industry, preferably with infusion pumps or similar electromechanical medical devices.
• Hands-on experience with System-Level Verification & Validation (V&V).
• Proven experience executing validation protocols, documenting results, and resolving validation issues.
• Strong understanding of design controls, validation processes, and quality systems.
• Excellent communication and documentation skills.
• Preferred: Experience working with FDA-regulated medical devices.
• Preferred: Knowledge of ISO 13485, 21 CFR Part 820, IEC 60601, and related medical device standards.
• Preferred: Previous experience with client or other leading medical device manufacturers.

Job Summary:

• We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products.
• The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements.
• Experience with infusion pump systems or similar electromechanical medical devices is preferred.

Roles & Responsibilities:

• Plan and execute system-level Verification & Validation (V&V) activities for medical device products.
• Develop, review, and execute validation protocols, test plans, and test reports.
• Perform validation testing, document results, investigate failures, and support issue resolution.
• Ensure validation activities comply with applicable quality standards, regulatory requirements, and internal procedures.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Systems Engineering.
• Support design verification, risk management, and product validation efforts.
• Maintain accurate documentation in accordance with FDA, ISO 13485, and company quality system requirements.
• Participate in design reviews and provide technical input related to system validation.

Education & Experience:

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 10 years of Validation Engineering experience.
• Strong experience in the Medical Device industry, preferably with infusion pumps or similar electromechanical medical devices.
• Hands-on experience with System-Level Verification & Validation (V&V).
• Proven experience executing validation protocols, documenting results, and resolving validation issues.
• Strong understanding of design controls, validation processes, and quality systems.
• Excellent communication and documentation skills.
• Preferred: Experience working with FDA-regulated medical devices.
• Preferred: Knowledge of ISO 13485, 21 CFR Part 820, IEC 60601, and related medical device standards.
• Preferred: Previous experience with client or other leading medical device manufacturers.

Controls Validation Engineer

Peoria, IL

Diversified Services Network, Inc. (DSN) is seeking a full-time Controls Validation Engineer to join our 2nd Shift team in Peoria, IL. We offer full benefits, PTO, 401k, and more! If you're looking to grow your career within an extremely reputable, stable Fortune 100 company - let's talk!

Position Overview

This role supports the validation of several machine platforms. Primary responsibilities center on supporting data collection runs, which are essential for documenting machine performance and verifying intended machine behavior.

Typical Day or Week in the Role

Task Breakdown

• Plan and execute data collection runs in coordination with the direct and indirect team, including software flashing, data transfer, and confirming machine readiness.
• Follow a defined set of steps to carry out each test, which will be provided to the selected applicant.
• Onsite five days a week, with daily exposure to machines and field testing in all types of weather; dressing appropriately for the day's conditions is important.
• This role is hands-on and outdoors-focused, working directly with machines on a regular basis.

Requirements

Candidate Requirements

Education & Experience

• Bachelor's degree in Engineering, Electrical Engineering, Manufacturing Engineering, or Mechanical Engineering preferred and a minimum 0-2 years of experience is required.

Top Skills (Required)

• Detailed planner
• Strong computer skills; Linux experience is a plus
• Problem solver
• Working knowledge of Ethernet and CAN, with the ability to troubleshoot related systems.
• Ability to confirm a system is fully functional before initiating data collection, and to upload collected data to servers for analysis.
• Strong communication skills, including coordinating schedules to accommodate testing requests.
• Strong organizational and planning skills.

Benefits

• 401(k)

• Dental insurance
• Vision Insurance
• Disability insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Paid Holidays

Please follow the link to our website for a list of job openings in Engineering, IT, Project Management, and more! (url removed)

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