Manufacturing Engineer

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. is seeking a Validation Engineer for an onsite role with a global industry leader near Warsaw IN. The Validation/Manufacturing Engineer supports process readiness, engineering changes, equipment activities, work instruction development, and manufacturing system implementation to ensure efficient and compliant site operation. Qualifications include a BS degree and 3+ years of engineering experience within a medical device manufacturing environment.

Salary Range: $40-43 per hour; salary negotiable based on experience, education, geographic location, and other factors

This is a great opportunity to get your foot in the door with a leading global employer!

Manufacturing Engineer Job Responsibilities Include:

• Support site Quality records such as NCR's, IE's, and CAPA's.
• Own and Review ECRs, ECNs, routers, BOM updates, and work instructions.
• Walk processes to assess readiness, risks, and implementation needs.
• Support equipment installation, qualification, validation, and decommissioning activities.
• Assist with protocol creation, execution support, and report activities tied to manufacturing changes.
• Support MES readiness and manufacturing master data activities.
• Use Windchill to review, manage, and support engineering documentation and change activity.
• Support InfoPV equipment qualification activities, including documentation, execution support, and traceability.
• Apply Gage R&R methods to evaluate measurement system capability and support process controls.
• Develop, review, and maintain control plans to ensure manufacturing process consistency and compliance.
• Support Vault DMR updates and maintain accuracy of controlled manufacturing records and related documentation.
• Partner with Operations and Quality to improve flow, efficiency, and manufacturability.

Qualifications:

• This role requires strong Windchill knowledge, equipment qualification/validation knowledge, Gage R&R experience, control plan knowledge, to support documentation accuracy, qualification activities, manufacturing controls, and design/manufacturing change
• BS degree in Engineering
• 3+ years of experience in validation engineering or manufacturing engineer in medical device environments

Equal Opportunity Employer/Veterans/Disabled

• Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan.
• Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs.
• In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
• Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

The Company will consider qualified applicants with arrest and conviction records