Job Title: Medical Device Validation Engineer
Job Summary:
The Medical Device Validation Engineer plays a critical role in the development and validation of medical devices and equipment manufactured to the highest standards. The successful candidate will ensure that medical devices comply with relevant regulations, industry standards, and quality criteria to guarantee patient safety and product effectiveness.
Responsibilities and Duties:
1. Design, develop, and execute validation plans, protocols, and reports for medical device products.
2. Conduct risk assessment and determine appropriate validation strategies for product development.
3. Collaborate closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to establish validation requirements and timelines.
4. Perform validation testing, including installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and cleaning validation as required.
5. Analyze and interpret validation data to ensure compliance with established specifications and standards.
6. Identify and troubleshoot issues that arise during the validation process, proposing solutions and preventive actions to mitigate risks.
7. Stay up-to-date with industry standards, regulatory changes, and advancements in medical device validation to ensure compliance and continuous improvement.
8. Maintain accurate documentation, including validation protocols, reports, standard operating procedures (SOPs), and change requests.
9. Collaborate with external vendors and suppliers to coordinate validation activities and ensure compliance with regulatory requirements.
10. Support audits and inspections related to medical device validation, responding to findings and implementing corrective actions.
Qualifications and Skills:
1. Bachelor's degree in engineering, biomedical sciences, or a related field. Advanced degree preferred.
2. Proven experience working in medical device validation, preferably in a regulated environment such as FDA, ISO, or EU MDR.
3. Strong understanding of regulatory requirements and industry standards pertaining to medical device validation, such as 21 CFR Part 820, ISO 13485, IEC 62304, and IEC 60601.
4. Expertise in designing and executing validation plans, protocols, and reports.
5. In-depth knowledge of risk assessment methodologies (e.g., FMEA, FTA) and statistical analysis techniques.
6. Proficiency in validation testing methods, including software validation, sterilization validation, and process validation.
7. Excellent analytical skills with the ability to analyze complex data sets and draw meaningful conclusions.
8. Strong communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams.
9. Detail-oriented mindset with a commitment to accuracy in documentation and adherence to quality standards.
10. Ability to prioritize tasks, handle multiple projects simultaneously, and meet tight deadlines.
#MedicalDeviceValidationEngineer #MedicalDeviceValidation #MedicalDeviceEngineer #MedicalDeviceIndustry #MedicalDevice #ValidationEngineer #QualityAssurance #RegulatoryCompliance #FDARegulation #ISOStandards #EU_MDR #EngineeringJobs #BiomedicalSciences #USJobs #JobOpportunity