Manufacturing Engineer I
Fusion Life Sciences
Title: Manufacturing Engineer I 37626295
Location: Warsaw, IN
Contract: 09/14/2026 - 09/10/2027
Job Summary
Principal Duties and Responsibilities
Skills:
Expected Areas of Competence
Education:
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.
Vacancy posted 2 days ago
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