Manufacturing Engineer

Manufacturing Engineer

Engineering

Manufacturing

$ 32 - $ 34 / Hour

location_onWarsaw, Indiana

acuteContractor

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Your Role

Akkodis is seeking a Manufacturing Engineer for a Contract with a client in Warsaw, IN. The ideal candidate will develop and execute validation strategies (IQ/OQ/PQ) while driving process improvements, ensuring regulatory compliance, and supporting cross-functional manufacturing operations.

Rate Range: $32/Hour to $34/Hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Manufacturing Engineer Job Responsibilities include:

• Develop and execute process validation strategies (IQ/OQ/PQ) for manufacturing processes including cleaning, packaging, and equipment qualification.

• Ensure compliance with FDA (21 CFR 820), ISO 13485, and internal quality standards while supporting audits and regulatory requirements.

• Analyze validation data, generate reports, and identify trends to drive continuous process improvements.

• Collaborate cross-functionally with Manufacturing, Quality, and Engineering teams to resolve issues and implement solutions.

• Lead root cause analysis, CAPA activities, and change management processes to address technical and process challenges.

• Create and maintain technical documentation including BOMs, routers, work instructions, and engineering specifications.

Required Qualifications:

• Bachelor's degree in mechanical, Biomedical, Aerospace Engineering, or a related discipline from an accredited institution.

• 4-6 years of experience in medical device manufacturing and process validation.

• Strong expertise in process validations (IQ/OQ/PQ), including equipment qualification, EOL validations, and test method validation within FDA/ISO regulated environments.

• Proven experience with root cause analysis, quality systems (CAPA, change management), and use of statistical tools (SPC, PFMEA) to drive continuous improvement.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at Deep.Kumar@akkodisgroup.com.

Pay Details: $32.00 to $34.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, 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.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.akkodis.com/en/us/candidate-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

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Ref: 1636472

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