Reliability Engineer II - Exempt

Join our dynamic team in Warsaw, IN, where innovation meets precision in the heart of the medical device industry. We are seeking a skilled Reliability Engineer II to play a pivotal role in ensuring the reliability and compliance of our cutting-edge projects.

• 1-3 years of experience in the Medical Device industry.
• Familiarity with FDA 21 CFR Part 820, EU 217/745 (EU MDR).
• Knowledge of standards: ISO 13485, ISO 14971, IEC 60601.
• Proficiency in Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
• Strong written and verbal communication skills.
• Ability to work cooperatively as part of a cross-functional team.
• 4 years of engineering experience in a medical device manufacturing environment.
• Ability to collaborate effectively with a wide range of stakeholders and internal customers.

• 5 years in validation of automated cells, Installation, Operational, and Performance Qualifications.
• Shot peen experience – Certified in shot peening, either level 1 or level 2.

• Ability to write validation master plans, Installation, operational, and performance qualification plans and reports with limited guidance.
• Understanding of software validation.
• Understanding of automation and how these systems get validated.

Engineering Degree (BS)

Responsibilities will include leading and executing validation activities associated with the installation, qualification, and lifecycle management of a new automated shot peening system, in alignment with applicable medical device regulatory requirements and industry standards, including FDA 21 CFR Part 820, ISO 13485:2016, and GAMP 5 guidance for automated systems.

This scope will encompass the development and approval of a comprehensive Validation Master Plan (VMP), as well as the generation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols to ensure the equipment consistently operates within defined specifications and meets intended use requirements. A risk-based validation approach will be applied in accordance with ISO 14971 principles to ensure appropriate rigor and traceability.

The primary focus will be the validation of the automated shot peening system; however, responsibilities will also include oversight of requalification and validation activities required for the restart of a fully automated rod cell. This system integrates machining, bending, inspection, and closed-loop autocorrection capabilities, requiring thorough assessment of process capability, software/controls validation considerations, and data integrity compliance.

Additionally, the project will involve coordination of facility and equipment modifications necessary to support the new installation. This includes the relocation or reconfiguration of adjacent equipment, as well as validation-impact assessments and qualification support for critical utilities such as compressed air systems and RO/DI water systems, ensuring they meet applicable process and quality requirements. All activities will be planned and executed to minimize disruption to ongoing manufacturing operations while maintaining compliance with change control and validation procedures.

Upon successful installation and validation of all impacted systems, the project will transition into a scale-up phase involving the introduction and qualification of additional rod product lines into the facility, ensuring continued compliance with process validation and production readiness requirements.