Manufacturing Engineer I

Fusion Life Sciences

Title: Manufacturing Engineer I 37626295

Location: Warsaw, IN

Contract: 09/14/2026 - 09/10/2027

Job Summary

Responsible for providing manufacturing validation engineering services. Position will support internal process validations with compliance to Code of Federal Regulations (CFR) section 820.75

Principal Duties and Responsibilities

Development, execution, and reporting of CFR 820.75 compliant process 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

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Skills:

Expected Areas of Competence

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 able 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 cross functionally to expedite completion of critical project tasks

Experience with CNC, Wire EDM, and Ram (sinker) EDM, is preferred

Knowledge of chemical vapor deposition processes is a plus

Knowledge of medical device cleaning, packaging and sterilization processes is preferred

Demonstrates excellent written and verbal communication skills

Microsoft Office Suite and Project; Statistical Process Control skills; proficient in process development, , and MINITAB statistical software

Knowledgeable in Good Manufacturing Practice and Good Documentation Practices

Education:

Education/ Experience Requirements

B.S. in mechanical, industrial, chemical engineering, or other engineering science plus 3-5 years of manufacturing process development or validation experience, or an equivalent combination of education and experience.

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Vacancy posted 1 day ago

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