Validation & Verification Engineer for multiple medical device projects at KICKMAKER. Collaborating with cross-disciplinary teams to ensure product compliance and quality standards.
Responsibilities
As a Verification & Validation Engineer, you will be responsible for designing, developing and qualifying product verification and validation test methods to demonstrate that the product meets the specifications.
Protocol Development: Design and implement verification and validation protocols for the design based on system requirements and approved procedures and standards (ISO, IEC and FDA).
Project Management: Identify tasks required to successfully complete projects in accordance with Design Control procedures. Propose technical solutions and associated schedules to deliver projects on time.
Test Benches: Design and build test benches while ensuring their maintenance and calibration.
Documentation: Create, analyze and summarize verification and validation results documentation for internal reviews and regulatory submissions.
Inspection and Testing: Oversee and perform inspection, assembly and verification/validation testing in accordance with product requirements.
Design Support: Assist in the development of design input requirements.
Procedures and Work Instructions: Participate in drafting and reviewing standard operating procedures and work instructions.
Supplier Management: Interact with and manage external suppliers, particularly regarding verification and validation testing.
Optimization: Help define, develop and implement processes and technical solutions to support current product designs, optimize manufacturing and reliability, and improve quality.
Requirements
Engineering degree in biomedical, mechanical, mechatronics or software engineering.
Prior successful experience in verification and validation (V&V).
Ideally, knowledge of ISO 13485 and FDA 21 CFR 820 standards.
Proficiency in statistical analysis methodologies for product testing.
Fluent English is required for documentation and communication.
Benefits
KICKMAKER works in robotics, medical, mobility, consumer electronics and connected devices with a strong maker culture.
Eco-design, combating planned obsolescence, durability, functional economy and local manufacturing are core areas of expertise, aimed at making the electronic products industry more mindful of CSR (corporate social responsibility) challenges.
As part of our international growth, you may have the opportunity to work on international projects and travel.
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