Senior Validation Engineer
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Overview
We are supporting a prominent medical device manufacturer in expanding their engineering team for high-visibility mammography product lines. This position plays a key role in enhancing manufacturing validation processes reinforcing quality systems and ensuring compliance through strong risk management and validation practices.
Key Responsibilities
- Review and strengthen existing PFMEAs by identifying failure modes risk gaps and improving mitigation controls.
- Lead and execute Process Validation activities (IQ/OQ/PQ) including protocol authoring execution and final reporting.
- Develop risk-based validation strategies and clearly define acceptance criteria with proper traceability to risk assessments.
- Perform and document Test Method Validation (TMV) to ensure accuracy reliability and compliance
- Drive deviation investigations conduct root cause analysis and implement effective corrective actions (CAPA).
- Ensure proper linkage between risk assessments validation activities deviations and change control within the QMS.
- Collaborate with Manufacturing Quality and cross-functional teams to maintain regulatory compliance and support continuous improvement initiatives.
Qualifications
- Bachelors degree in Engineering (Mechanical Biomedical Industrial or related)
- 4-5 years of medical device experience
- Experience with established med device companies (e.g. Stryker Johnson & Johnson)
- Strong experience in Process Validation (IQ/OQ/PQ) and Test Method Validation (TMV)
- PFMEA and remediation experience preferred
- Knowledge of FDA regulations and ISO 13485
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
