Reliability Engineer

The ideal candidate will have strong hands-on experience developing validation documentation, executing IQ/OQ/PQ protocols, supporting automated manufacturing systems, and working cross-functionally with manufacturing, quality, automation, and process engineering teams., * Lead validation activities for the installation and qualification of a new automated shot peening system.

• Develop, review, and approve validation documentation, including:
• Validation Master Plans
• Installation Qualification protocols and reports
• Operational Qualification protocols and reports
• Performance Qualification protocols and reports
• Validation summary reports
• Apply a risk-based validation approach in accordance with ISO 14971 principles.
• Ensure automated equipment consistently operates within defined specifications and meets intended use requirements.
• Support software validation and controls validation considerations for automated systems.
• Provide validation oversight for the restart and requalification of a fully automated rod cell.
• Assess systems integrating machining, bending, inspection, and closed-loop autocorrection capabilities.
• Evaluate process capability, data integrity, and validation impact for automated manufacturing equipment.
• Coordinate validation-impact assessments related to equipment relocation, reconfiguration, and facility modifications.
• Support qualification activities for critical utilities, including compressed air systems and RO/DI water systems.
• Ensure all validation and qualification activities comply with change control, quality system, and manufacturing procedures.
• Partner with manufacturing, quality, automation, facilities, and engineering teams to minimize production disruption while maintaining compliance.
• Support scale-up activities involving introduction and qualification of additional rod product lines into the facility., This role will support a project involving the installation of a new shot peening machine, the restart of an automated rod cell, and related equipment and utility changes required to support manufacturing operations. The position requires close collaboration with onsite engineering, quality, facilities, automation, and manufacturing teams.

• Bachelor's degree in Engineering required.
• 4+ years of engineering experience in a medical device manufacturing environment.
• 1-3+ years of medical device industry experience.
• Experience writing validation master plans, IQ/OQ/PQ protocols, and validation reports with limited guidance.
• Understanding of software validation requirements for automated systems.
• Understanding of automation systems and how automated manufacturing equipment is validated.
• Familiarity with FDA 21 CFR Part 820 and EU MDR 2017/745.
• Familiarity with ISO 13485, ISO 14971, and IEC 60601.
• Strong knowledge of Microsoft Office applications, including Word, Excel, Access, and PowerPoint.
• Strong written and verbal communication skills.
• Ability to collaborate effectively with cross-functional stakeholders, including manufacturing, quality, process engineering, and automation engineering teams.

Preferred Qualifications

• 5+ years of experience validating automated manufacturing cells.
• Strong experience with Installation Qualification, Operational Qualification, and Performance Qualification activities.
• Experience with shot peening processes.
• Shot peening certification, Level 1 or Level 2, preferred.
• Experience supporting equipment restart, requalification, or manufacturing scale-up projects.
• Experience with automated cells involving machining, inspection, closed-loop correction, or integrated controls., The ideal candidate is a hands-on validation engineer with strong medical device manufacturing experience and the ability to independently drive validation deliverables from planning through execution. This person should be comfortable working in a highly regulated environment, partnering with multiple technical teams, and supporting complex automated equipment validation projects from installation through production readiness.

3.83.8 out of 5 stars Warsaw, IN 46582 $40 - $55 an hour - Contract, Pulled from the full job description

• 401(k)
• Dental insurance, * 401(k)
• Dental insurance