Manufacturing Sr Engineer II

Zimmer Biomet • Claymont, DE • 3h ago

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 patient's 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.

What You Can Expect

The Manufacturing Sr. Engineer II is responsible for providing manufacturing engineering services to support efficient manufacturing processes. This is an experienced position. The individual is responsible for supporting the daily production and testing needs of a Reagent Manufacturing team. This includes investigation and resolution of assay failures during in-process or final testing. Including material specification changes due to new material qualification or supplier changes and updating/correcting SOPs in compliance with current quality system standards. This position will support the routine production and testing of reagents for IVD assays. All work will be in compliance with governing regulatory requirements such as FDA, ISO 13485, and QSR. Experience with immunoassays is required, ELISA and lateral flow technology is preferred.

How You'll Create Impact

Provide technical expertise and direction in multiple Immunoassay manufacturing areas Lead multi-department teams to support/resolve non-conforming issues for existing products Communicate investigation status reports, proposals for further investigation, etc. via oral and written reports; develop and implement changes to existing documentation in a timely manner Solve immunoassay testing and manufacturing issues as they arise Assess manufacturing processes and systems, and implement improvements aimed at performance, quality, and cost Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements Lead equipment qualification or process validation projects. Create protocols, execute, draw conclusions and author reports Interpolate and analyze data using statistical analysis (including control charts) Create and revise standard operating procedures including periodic review. Manage the documentation associated with the Change Control process. Author review and manage quality events including NCRs, Issue Evaluations, and CAPAs. Understands, promotes, and enforces all applicable safety protocols including chemical, biological hazards, labeling, containment, and waste handling. Understand product application and customer expectations Work as a member of interdepartmental project teams

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

Candidates with practical experience in the development, validation and/or manufacture of diagnostic assays is required Work experience with ELISA assays is preferred ISO 13485 or cGMP experience preferred Ability to lead and prioritize complex projects and complete work in a timely manner The ability to read, interpret and analyze scientific data is required. The ability to effectively communicate through written and oral form is required, along with strong organizational and time management skills Ability to define problems, collect data, establish facts, and draw valid conclusions Good problem-solving skills through the use of quality and statistical tools Experience using Microsoft Suite - Word, Excel, Visio, and Project Minitab knowledge is preferred.

Your Background

B.S.in Engineering with a minimum of 5-7 years of manufacturing engineering experience Minimum 4 years of experience in a relevant production/manufacturing environment. Knowledge of FDA and ISO 13485 regulations as they relate to medical devices and/or in-vitro diagnostics devices. Experience in the in-vitro diagnostics devices field desired Knowledge in Lean Principles and or Six Sigma or other problem-solving methodology is preferred. Knowledge on how to conduct investigations and root cause analysis is preferred.

Travel Expectations

Up to 5%.

EOE/M/F/Vet/Disability

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