Join to apply for the Operations Engineer 2 role at Evergen
This range is provided by Evergen. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$83,000.00 / yr - $93,000.00 / yr
Location : West Lafayette, IN
Responsibilities
- Lead process improvement projects to elevate constraints and eliminate waste.
- Complete sustaining activities including OOS / OOSC forms, supplier change notifications, dose audits, and validation reviews.
- Facilitate and / or complete Corrective and Preventive Action (CAPA) activities.
- Solve problems using root cause analysis methodologies (e.g. 5 whys, fishbone analysis).
- Use statistical analysis tools and methodology to drive process improvement projects and decision making.
- Complete process validations.
- Procure and qualify equipment, tools and instruments (ETI).
- Generate technical drawings of ETI using 3D CAD software.
- Write and revise quality system documents.
- Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties.
- Other corporate duties as required.
Education
Bachelor of Science Degree in Engineering or related field, or equivalent experienceExperience
At least 3 years of experience in engineering or related fieldSkills
Excellent verbal and written communicationWilling to work with material derived from animal tissuesGood record keeping and documentation skillsAble to create and interpret technical drawingsAble to understand and apply basic statisticsSafety
Limited exposure to hazardous chemicalsPhysical Requirement
Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
Working Environment
Onsite : Office environment with assigned workstation
Seniority level
Mid-Senior levelEmployment type
Full-timeJob function
Engineering and Information TechnologyIndustries
Medical Equipment ManufacturingJ-18808-Ljbffr