Process Engineer Sr I

Zimmer GmbH; Claymont (DE); On-site; USD 80,000 - 115,000; Full time

Job summary

Zimmer GmbH is seeking a Process Engineer Senior I to support validation activities essential for medical devices. This role involves protocol drafting, data collection, and collaboration across functional areas while adhering to FDA and ISO regulations. The ideal candidate will have extensive experience and a Bachelor's degree in Engineering.

Qualifications

• Must have 3 years of experience in job offered or related position.
• Must have 2 years in FDA and ISO 13485 regulations and in-vitro diagnostics.
• Must have 1 year of experience in Test Method Validation.

Responsibilities

• Support validation activities: collect and review data for validations.
• Draft validation protocols and reports; write user/functional requirements specifications.
• Perform validation project management duties as needed.

Skills

FDA regulations

ISO 13485

statistical sampling

blueprint reading

gauging concepts

geometrical dimensions

tolerance

Education

Bachelor’s in Engineering

Job description

Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!

What You Can Expect

The Process Engineer Senior I supports validation activities through performing the following: Collect and review data for assigned process validations, test method validations and IQ/OQ/PQs; Draft validation protocols and reports; Review and prepare supporting documentation, including SOPs, for assigned validations; Coordinate documentation reviews with other functional areas and assure approvals are completed as required; Write, develop, review, revise, and, as applicable, execute user/functional requirements specifications, risk assessments, validation plans, IOPQ protocols, decommissioning plans, trace matrices and final reports for equipment/processes, CSV/Software; and Perform validation project management duties as needed.

How You'll Create Impact

What Makes You Stand Out

Must have 3 years of experience in job offered or related position.

Must have 2 years of experience with the following:

• working with FDA and ISO 13485 regulations as they relate to medical devices and/or in-vitro diagnostics devices;
• working in the in-vitro diagnostics devices field; and
• statistical sampling, blueprint reading, gauging concepts, and geometrical dimensions and tolerance.

Must have 1 year of experience in Test Method Validation.

Your Background

• Requires a Bachelor’s in Engineering or related field

Travel Expectations

• Role requires up to 5% domestic travel.
• 40 hours per week, Monday through Friday, 8:30 AM to 5:00 PM

CD Diagnostics Inc., 650 Naamans Road, Suite 100, Claymont, DE 19703

EOE/M/F/Vet/Disability