Onsite Manufacturing & Validation Engineer – Medical Devices

Akkodis; Warsaw (IN); On-site; USD 55,000 - 59,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401K plan

Job summary

Akkodis, Inc. seeks a Validation Engineer for an onsite role near Warsaw, IN. The position supports process readiness, equipment qualification, and manufacturing changes to ensure compliant site operation in a medical device environment.

Ideal candidates hold a BS in Engineering with 3+ years of validation/manufacturing engineering experience, and hands-on Windchill, Gage R&R, control plans, and MES readiness expertise.

Qualifications

• BS degree in Engineering (required)
• 3+ years of validation/manufacturing engineering experience in medical device environments
• Strong Windchill knowledge and equipment qualification/validation experience
• Knowledge of Gage R&R, control plans, and manufacturing documentation practices

Responsibilities

• Support site quality records (NCRs, IE/ CAPA) and review ECRs/ECNs
• Walk processes to assess readiness, risks, and implementation needs
• Support equipment installation, qualification, validation, and decommissioning activities
• Assist with protocol creation, execution, and reporting tied to manufacturing changes
• Support MES readiness and manufacturing master data activities
• Review and manage engineering documentation using Windchill and related systems
• Maintain Vault DMR updates and controlled manufacturing records
• Collaborate with Operations and Quality to improve flow and manufacturability

Skills

Windchill knowledge

Equipment qualification/validation

Gage R&R experience

Control plan knowledge

Education

BS degree in Engineering

Tools

Windchill

InfoPV

Vault DMR

Job description

Akkodis, Inc. seeks a Validation Engineer for an onsite role near Warsaw, IN. The position supports process readiness, equipment qualification, and manufacturing changes to ensure compliant site operation in a medical device environment.

Ideal candidates hold a BS in Engineering with 3+ years of validation/manufacturing engineering experience, and hands-on Windchill, Gage R&R, control plans, and MES readiness expertise.