Senior Product Reliability Specialist
4 days ago
We are seeking a seasoned Sustaining Engineer to support our products through their full lifecycle. The ideal candidate will have over 10 years of hands-on experience in implementing design changes, driving CAPA initiatives, performing root cause analysis, improving product reliability, and ensuring comprehensive documentation.
The successful candidate will be responsible for mentoring and upskilling engineers, sharing best practices, and enabling continuous improvement in sustaining engineering processes across multiple industries.
- Main Responsibilities:
- Train and mentor engineering teams on sustaining engineering principles and practices.
- Support product lifecycle management from post-launch support to end-of-life.
- Guide teams in implementing design changes and product modifications efficiently.
- Lead CAPA investigations, ensuring corrective and preventive actions are properly executed.
- Conduct detailed root cause analysis to identify and resolve recurring product issues.
- Promote reliability improvement initiatives and preventive maintenance strategies.
- Ensure accurate and compliant documentation according to industry standards (ISO, FDA, cGMP).
Required Skills & Competencies:
- Strong expertise in product lifecycle support and sustaining engineering.
- Proficient in root cause analysis techniques (5-Why, Fishbone, FMEA).
- Experience driving CAPA processes and quality improvement initiatives.
- Knowledge of regulatory requirements and standards (ISO 13485, FDA, CE).
- Understanding of design changes, engineering change requests (ECR/ECO), and change management.
- Ability to improve product reliability and performance metrics.
- Excellent documentation, reporting, and technical writing skills.
- Hands-on experience with the maintenance of multi-industry products, including medical devices, automotive, and electronics.
- Strong mentoring, coaching, and presentation skills.
- Analytical thinking, problem-solving, and decision-making capabilities.
Key Performance Indicators:
- Product reliability and performance metrics.
- Process efficiency and effectiveness.
- Quality improvement initiatives.
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