Sr. Engineer Manufacturing - Medical Devices

Merz North America, Inc.; Racine (WI); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Comprehensive Medical, Dental, and Vision plans

20 days of Paid Time Off

15 paid holidays

401(k)

Job summary

Merz North America, Inc. in Racine, Wisconsin is looking for a Senior Engineer in Manufacturing for medical devices. This role requires 7+ years of experience in a regulated industry with a focus on electro-mechanical devices. Key responsibilities include leading manufacturing process improvements, ensuring regulatory compliance, and collaborating with cross-functional teams. Excellent problem-solving and project leadership skills are essential. The position offers comprehensive benefits including health plans and paid time off.

Qualifications

• 7+ years in a regulated industry.
• 3-5 years experience in manufacturing or support.
• Experience with electro-mechanical devices preferred.

Responsibilities

• Support production continuity and troubleshoot issues.
• Lead process improvements to enhance productivity.
• Ensure compliance with FDA and ISO regulations.
• Collaborate with cross-functional teams.
• Develop and maintain design documentation.

Skills

Project leadership

Problem-solving skills

Communication skills

Understanding of process validation

Six Sigma methodologies

Education

Bachelor's Degree in Biomedical, Industrial, Manufacturing, Electrical, or Mechanical Engineering

Master's Degree preferred

Job description

Sr. Engineer Manufacturing - Medical Devices

Job Category: Engineering Generalist/Multidiscipline

A Brief Overview

An experienced engineer, with a device engineering foundation in a regulated environment heavily focused on manufacturing processes (validation, qualification, process improvements, design transfer, efficiency, supplier management). Ensures process qualification, product reliability, manufacturability, and regulatory compliance are maintained, through cross‑functional collaboration, rigorous testing, and continuous process improvement. Able to work with minimal guidance on larger process/product improvements while providing indirect mentorship.

What You Will Do

• Manufacturing and Sustaining Focus Support production critical manufacturing and supply continuity issues. Lead and manage complex and critical activities related to maintaining and improving electro‑mechanical medical device manufacturing, process optimization, and design via internal and Contract Manufacturing Organizations. Lead, with minimal oversight, the implementation of manufacturing equipment, process expansions, new initiatives, and process automation. Includes project budgeting, design & interfacing with vendors of equipment and tooling, and maintaining appropriate documentation for new equipment and processes including qualification, verification, and validation. Lead troubleshooting activities, investigate the root cause to a successful conclusion, and help to resolve manufacturing process related issues, product complaints and CAPA.
• Process Improvements Lead and identify improvements in manufacturing equipment/process and product design to improve productivity and quality of current and future products while expecting cost reductions.
• Collaboration Work closely with cross‑functional teams, including mechanical and electrical engineers, contract manufacturing organizations, quality, suppliers, and regulatory, to ensure device safety, manufacturability, compliance, compatibility, functionality, and serviceability.
• Regulatory Compliance Ensure that device complies with relevant regulations and standards (e.g., FDA, CE Mark, IEC 60601 series, ISO 13485, GMP).
• Documentation Develop and maintain detailed drawings. Documentation of design processes and test results. Execute the Engineering Change Order (ECO) process per Design Controls – Design Change regulations and internal policies. Support regulatory submissions.
• Leadership Indirectly mentor junior engineers. Proactively identify process improvements through proposal of resources, budget, risk, and return on investment.
• Other Duties Assigned Perform other duties as needed including review of test. Plans and reports, maintaining project deliverables, and other general engineering related tasks.
• Bachelor's Degree Biomedical, Industrial, Manufacturing, Electrical, or Mechanical Engineering.
• 7+ years Experience in a regulated industry.
• 3-5 years Experience in manufacturing/support, systems, or sustaining.

Preferred Qualifications

• Master's Degree Biomedical, Industrial, Manufacturing, Electrical, or Mechanical Engineering.
• 8-10 years experience
• Majority experience in healthcare industry specifically with electro‑mechanical devices directly managing manufacturing operations.
• Experience with ultrasound technologies.

Technical & Functional Skills

• Demonstrated ability to lead projects with large scope and high technical complexity.
• Strong technical and problem‑solving skills.
• Ability to communicate and write effectively.
• Emotional self‑management in difficult situations.
• Understanding and application of process validation and statistical analysis.
• Understanding and application of ISO 13485 quality management system requirements.
• Understanding and application of FDA Design Controls and/or EU Medical Device Directive (CE Marking requirements).
• Familiar with electro‑mechanical manufacturing, depot service, and field service processes and operations.
• Experience with system level requirements definition cascading down to process controls.
• Experience with system level requirements definition cascading down to process control.
• Demonstrated ability to identify and implement process improvements, increase efficiency, cost improvements, and standardization.
• Experience with designing and implementing manufacturing, mechanical, or electrical solutions to complex technical problems.
• Practical knowledge of Six Sigma methodologies. Green or Black Belt certification.

Your benefits and PTO start the date you're hired with no waiting period!

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• 401(k)

This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.