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
Responsible for providing engineering services to support production in the manufacturing business units. The successful candidate will be tasked with driving process improvement using continuous improvement tools while maintaining the high-quality standards in the area. The candidate for this role will be tasked with setting up the manufacturing process and equipment as part of the start up of the facility and will need to demonstrate strong project management skills to deliver the project on time and within budget.
How You'll Create Impact
- Apply Lean Manufacturing, Six Sigma, Kaizen, Value Stream Mapping (VSM), 5S, SMED, Kanban, waste elimination, and Overall Equipment Effectiveness (OEE) to improve productivity, quality, and cost.
- Plan and execute engineering projects involving timelines, budgets, resources, validation activities, and stakeholder communication.
- Manage engineering changes through formal change control systems while assessing product quality, regulatory, and business impacts.
- Design, develop, validate, optimize, and sustain manufacturing processes for orthopedic implants.
- Establishing preliminary bill of materials and routers and maintenance of the master data on ongoing basis.
- Plan and execute IQ, QQ, PQ, process validation protocols, equipment qualification, cleaning validation, and revalidation activities in accordance with regulatory expectations.
- Lead investigations using 5 Why, Fishbone Diagram, Fault Tree Analysis (FTA), Pareto Analysis, DMAIC, and corrective/ preventive action (CAPA) methodologies.
- Be proficient in manufacturing transfer activities including the transfer of process knowledge, competion of transfer documentation requirements and the setup of initial equipment.
- Perform capability analysis, analyze trends and use statistics to help troubleshoot process issues.
- Responsible for completing risk safety, risk assessments in the area, ensuring new equipment installations don't introduce additional risk and responding to safety incidents should they occur.
- Identifies and delivers cost reduction initiatives through consumable reduction, yield improvement, productivity gains etc.
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
- Knowledge of workplace safety, machine guarding, ergonomics, chemical handling, risk assessments, and environmental compliance.
- Proficiency in Process Validation and Equpment qualifications including execution and protocol development.
- Experience with ERP systems, Manufacturing Executiron Systems (MES), statistical software (Minitab), CAD software, Microsoft Office, and document management systems.
- Competence in Statistical Process Control (SPC), process capability (Cp/ Cpk), Design of Experiments (DOE), Measurement System Analysis (MSA), Gage R&R, trend analysis, and data-driven decision making using statistical software (e.g., Minitab).
- Understanding of applicable regulatory requirements including MDR, FDA requirements, Good Manufacturing Practive (GMP), and applicable guidance documents affecting orthopedic device manufacturing.
- Knowledge of process risk assessments, PFMEA, DFMEA, Control Plans, and mitigation strategies throughout the product lifecycle.
Your Background
- B.Eng in manufacturing, mechanical, biomedical engineering, or other engineering science plus 0-3 years of experience in medical device manufacturing, or an equivalent combination of education and experience.
Travel Expectations
- Up to 10%
EOE/M/F/Vet/Disability