Reliability Engineer II

Job overview

The Reliability Engineer II role is onsite in Warsaw, IN. Compensation is $40–$45 per hour. The role supports validation and compliance work for medical device manufacturing projects. The engineer leads validation activities for an automated shot peening system and supports requalification and validation for a fully automated rod cell. This work helps ensure equipment and processes meet defined specifications, intended-use requirements, and applicable regulatory and quality standards while supporting production readiness.

What you'll do

• Develop and approve a Validation Master Plan
• generate and execute Installation Qualification, Operational Qualification, and Performance Qualification protocols
• validate an automated shot peening system
• oversee requalification and validation for restart of a fully automated rod cell
• assess process capability, software and controls validation, and data integrity
• coordinate facility and equipment modifications and qualification support for critical utilities
• support scale-up and qualification of additional rod product lines.

What we're looking for

Skills & competencies

reliability engineer ii

medical device

validation

automated shot peening

iq/oq/pq

validation master plan

iso 13485

iso 14971

warsaw in

lancesoft

$40–$45/hr

Work arrangement

• Weekend coverage required

Why this role

The posting identifies FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, and GAMP 5, with shot peening certification and automated-cell validation listed as nice to have.

About the employer

LanceSoft Inc is hiring for this role. Industry: Engineering Services. Sector: 54.