Senior R&D Engineer – Verification & Validation
Hydrogen Group ·www.hydrogengroup.com
Apply directSenior R&D Engineer – Verification & Validation
Location: Naperville, IL (Onsite)
Contract: 6 Months
Pay Rate: Up to $83.33 per hour
Our client is seeking an experienced Senior R&D Engineer to support product development and verification activities for innovative medical devices.
The successful candidate will lead verification and validation testing, risk management activities, technical documentation, and design change assessments while collaborating with cross-functional engineering teams to ensure products meet quality, safety, and regulatory requirements.
Responsibilities
- Lead verification and validation (V&V) activities, including protocol development, test execution, data analysis, and technical report writing.
- Perform design change impact assessments to support product lifecycle activities.
- Conduct product risk management activities including Hazard Analysis, Design FMEAs, and Use FMEAs.
- Support product labeling reviews to ensure compliance with applicable standards and regulatory requirements.
- Develop sampling procedures, quality documentation, and reporting methods for evaluating product quality and reliability.
- Design and implement methods for evaluating production equipment, testing equipment, measurement systems, and analytical processes.
- Analyse testing results and recommend product or process improvements.
- Support quality engineering initiatives across product development and manufacturing.
- Develop technical documentation supporting design verification, validation, and regulatory submissions.
- May develop training materials and deliver technical training related to quality and verification activities.
- Partner closely with Quality, Regulatory Affairs, Manufacturing, and R&D teams to support product development and commercialisation efforts.
- Direct and support engineers and technicians involved in product testing, measurement, and quality evaluation.
Required Qualifications
- Bachelor's degree in Engineering.
- Minimum 5-7 years of engineering experience.
- Strong experience leading verification and validation testing within regulated product development environments.
- Experience writing V&V protocols, executing testing, analysing results, and preparing technical reports.
- Experience conducting design change impact assessments.
- Strong understanding of risk management methodologies including Hazard Analysis, Design FMEA, and Use FMEA.
- Knowledge of product labeling requirements and compliance standards.
- Excellent technical writing and documentation skills.
- Demonstrated ability to work independently while managing multiple priorities.
- Strong analytical, troubleshooting, and problem-solving skills.
- Excellent written and verbal communication skills.
Preferred Experience
Experience within highly regulated industries such as:
- Medical Devices
- Biotechnology
- Pharmaceutical
- Aerospace
- Life Sciences
Experience supporting:
- Product development
- Design verification
- Product validation
- Risk management
- Quality engineering
- Regulatory compliance
- New product introduction (NPI)
Ideal Candidate
The successful candidate will be a detail-oriented engineer with strong verification and validation expertise who enjoys solving complex technical challenges and working collaboratively across multidisciplinary teams. You'll thrive in a fast-paced R&D environment while ensuring products meet the highest standards of quality, safety, and regulatory compliance.
This is an excellent opportunity to contribute to cutting-edge medical device development while working alongside experienced engineering professionals on impactful projects.
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