Design Validation Engineer

More than 10 years of project experience in product development and Design Validation including the whole documentation within medical devices industry

Throughout his career this candidate has gained expertise in many different companies, ranging from small startups to big companies with matrix organizations

Gained experience and worked with a broad range of medical device products with different risk classes (I, IIa, IIb and III)

Develop and execute validation plans for medical device designs, including design verification, validation testing, risk management, and failure mode analysis

Collaborate with cross-functional teams, including design engineers, quality engineers, regulatory affairs, and product managers to meet design validation requirements

Analyze validation test results, document findings, and suggest design improvements

Ensure compliance with FDA regulations, ISO standards, and medical device industry best practices

Develop and maintain design validation documentation, including protocols, reports, and risk management documents

Participate in design reviews and provide feedback on validation activities to ensure product safety and efficacy

Verify medical device functionality, performance, and compliance with FDA and ISO standards via testing

Maintain the DHF throughout product development, ensuring thorough documentation and traceability of design changes

Analyze test results and provide recommendations for medical device improvements based on test data

Collaborate across teams to ensure medical device designs meet customer and business needs

Stay current with industry trends in medical device design validation and testing methodologies, incorporating best practices into the validation process

Effectively document and communicate design validation activities to stakeholders, including regulatory authorities

Lead medical device development and launch in compliance with FDA and CE requirements

Manage project timelines, budgets, and resources for successful product development and launch

Collaborate with R&D to develop new product concepts, including design inputs, specifications, and risk management

Coordinate with cross-functional teams, including engineering, manufacturing, quality, and regulatory, to ensure successful product development

Develop and execute testing plans to meet customer needs and regulatory requirements

Conduct market research to identify trends and new product opportunities

Maintain relationships with key stakeholders, including customers, vendors, and regulatory agencies

Lead product development of implants and instruments from concept to market release under ISO 13485 QMS

CAPA Management

Concept creation of new spinal implants leading to three patent applications

Generation of complete technical files DHF and DMR for CE mark submission

FMEA, design verification and validation, IFU, Surgical Technique, re-processing guides

Manage design transfer from product design into manufacturing specifications

Design and develop medical implants and instruments to meet specific surgical requirements

Create DFMEA and PFMEA risk management documentation in line with the PDP

Create design specifications with design verification and validation techniques and documentation

Provide support for quality, regulatory affairs and production

Coordinate technical activities within product validation and product testing

Ensuring compliance with FDA and CE regulations