Process Engineer Sr I

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patients mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

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.

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.

• 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