Medical Device Manufacturing Engineer; Cleaning Validation

Akkodis is seeking a Medical Device Manufacturing Engineer (Cleaning Validation)

Position: 18-month job with a client in Warsaw, IN. Seeking manufacturing cleaning validation engineering services. Onsite. Rate Range: $40.00/hour to $45.00/hour. The rate may be negotiable based on experience, education, geographic location, and other factors.

• Development, execution, and reporting of CFR 820.75 compliant process validations, specifically cleaning validations.
• Identification of key calibration requirements for equipment installation activities.
• Equipment Installation Qualification for medical device production.
• Equipment calibrations for medical device production.
• Operational Qualification execution for medical devices.
• Production Qualification execution for medical devices.
• Statistical interpretation of attribute and variable results.
• Prepare validation summary reports.

• B.S. in mechanical, industrial, chemical engineering, or other engineering science, plus 1-2 years of manufacturing process development or validation experience in medical device or pharmaceutical manufacturing.
• Skilled and knowledgeable in medical device manufacturing and product processing.
• Knowledge of drafting standards and geometric dimensioning and tolerancing.
• Demonstrates ownership of and ability to manage project assignments with a broad scope and high level of complexity and to prioritize and complete work in a timely manner.
• Demonstrates advanced problem‑solving skills through the use of quality and statistical tools.
• Ability to effectively work within a team and across functions to expedite completion of critical project tasks.
• Knowledge of chemical vapor deposition processes is a plus.
• Knowledge of medical device cleaning processes is required.
• Demonstrates excellent written and verbal communication skills.
• Microsoft Office Suite and Project;
  Statistical Process Control skills; proficient in process development, MINITAB statistical software, and Windchill PLM.
• Knowledgeable in Good Manufacturing Practice and Good Documentation Practices.

Benefit offerings include medical, dental, vision, life insurance, short‑term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401(k) plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, associates may be eligible for paid leave including paid sick leave or other paid leave required by federal, state, or local law, as well as holiday pay where applicable.

We 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, and Los Angeles County Fair Chance Ordinance for Employers.