What are the responsibilities and job description for the Manufacturing Sr Engineer II position at Zimmer Biomet?

JOB DESCRIPTION

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 talented 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 inspired, invested, cared for, valued, and have a strong sense of belonging.

What You Can Expect

The Manufacturing Sr. Engineer II is responsible to drive process improvement and process optimization, equipment lifecycle management, and regulatory compliance, ensuring high production efficiency, quality, and cost-effectiveness. This role is integral in leading process validation, equipment qualification, and continuous improvement initiatives while upholding safety standards. The ideal candidate will collaborate cross-functionally with Operations, Quality, R&D and Supply Chain to implement best practices and cutting-edge manufacturing technologies.

How You'll Create Impact

Develop, maintain and improve controlled technical documentation (prints, procedures, work instructions, specifications, acceptance tests, commissioning plans, transfer documents, and master plans)
Deep understanding of manufacturing processes used in medical device production and supporting a wide variety of processing applications such as biomaterial transformations and packaging
Analyze and improve existing manufacturing processes to enhance efficiency, yield, and cost savings
Implement lean manufacturing and Six Sigma methodologies to reduce waste and variability
Collaborate with Product Development teams to transition new products from design to full-scale production
Lead and manage complex projects with high-impact deliverables, ensuring timely execution
Lead equipment qualification or process validation projects to maintain compliance and operational excellence
Identify and resolve complex product and process performance issues
Hands on approach to selection, installation, troubleshooting, diagnostic and repair of manufacturing equipment
Design, develop, and implement new manufacturing equipment, fixtures, and tools to enhance production capabilities
Ensure compliance with ISO 13485, FDA 21 CFR Part 810, GMP and EU MDR standards

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

Sound understanding of concepts and principles for manufacturing and new product processing and a basic knowledge of these elements in areas such as Quality, Development, or Sourcing.

Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.

Extensive knowledge of mechanisms required to implement processes and manage product flow

Full working knowledge of the development process and procedures.

Competence with drafting standards and geometric dimensioning and tolerancing

Ability to balance marketing, manufacturing, and design requirements to meet customer requirements

Ability to lead and prioritize complex projects assignments and complete work in a timely manner

Good problem-solving skills through the use of quality and statistical tools

Ability to effectively work and communicate within a cross-functional team to complete critical project tasks.

Demonstrates good written and verbal communication skills.

Microsoft Office Suite and Project.

Minitab knowledge is preferred.

Expertise in equipment qualification, process validation, and risk management

Experience with CAD software, PLM systems, and engineering tools

Ability to manage multiple priorities in a fast-paced, dynamic environment

Strong analytical and problem-solving skills, including root cause analysis, data analysis, statistical methods, FMEA, and CAPA investigations

Working knowledge of ERP / MRP systems to support production planning and efficiency

Your Background

B.S. in Engineering required.

5-7 years of manufacturing engineering experience in a regulated industry (pharmaceutical, biotech, medical device, aerospace, automotive, etc.) preferred

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 10% travel may be required

EOE / M / F / Vet / Disability

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