Process Engineer

As a Process Engineer at Zimmer Biomet in Costa Rica, you will be responsible for supporting and improving manufacturing processes, particularly in the medical device sector. The role involves applying Lean Manufacturing, Six Sigma, and other continuous improvement tools, managing engineering projects, and ensuring compliance with regulatory standards. You will design and optimise manufacturing processes, lead risk assessments, and support equipment qualification and validation. The position requires a BEng in engineering (or equivalent) with 0–3 years of relevant experience, proficiency in process validation, ERP/MES systems, and statistical software. Knowledge of workplace safety, regulatory requirements, and risk management is essential. Travel up to 10% may be required.

As a Process Engineer at Zimmer Biomet in Costa Rica, you will play a pivotal role in supporting production within the manufacturing business units. The position focuses on driving process improvement initiatives using continuous improvement tools, ensuring high-quality standards, and maintaining robust project management. You will be responsible for setting up manufacturing processes, managing engineering projects, and leading investigations to enhance productivity and safety. The role requires strong project management skills, proficiency in process validation, and a commitment to regulatory compliance. Zimmer Biomet offers a flexible working environment, development opportunities, and a culture of recognition, empowering you to make a meaningful impact on patient mobility worldwide.

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

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

Responsibilities:

• Responsible for providing engineering services to support production in the manufacturing business units.
• Play a key role in shaping process improvement using Lean Manufacturing, Six Sigma, Kaizen, Value Stream Mapping, 5S, SMED, Kanban, waste elimination, and Overall Equipment Effectiveness to improve productivity, quality, and cost.
• Take ownership of planning and executing 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.
• Deliver high-quality manufacturing process and equipment setup as part of facility start-up, demonstrating strong project management skills.
• Lead efforts to design, develop, validate, optimise, and sustain manufacturing processes for orthopaedic implants.
• Collaborate cross-functionally to establish preliminary bill of materials, routers, and maintain master data on a 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, Pareto Analysis, DMAIC, and corrective/preventive action methodologies.
• Responsible for completing risk safety, risk assessments, and ensuring new equipment installations do not introduce additional risk, and responding to safety incidents as they occur.

Skills:

• Demonstrated knowledge of workplace safety, machine guarding, ergonomics, chemical handling, risk assessments, and environmental compliance.
• Proficiency in process validation and equipment qualifications, including execution and protocol development.
• Experience with ERP systems, Manufacturing Executronic Systems (MES), statistical software such as 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.
• Understanding of applicable regulatory requirements including MDR, FDA requirements, Good Manufacturing Practice (GMP), and applicable guidance documents affecting orthopaedic device manufacturing.
• Knowledge of process risk assessments, PFMEA, DFMEA, Control Plans, and mitigation strategies throughout the product lifecycle.

Education:

• A B.E. in manufacturing, mechanical, biomedical engineering, or other engineering science is required, plus 0-3 years of experience in medical device manufacturing, or an equivalent combination of education and experience.