Senior Manufacturing Engineer

Introduction

Werfen

 

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

 

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Job Summary

 

The Senior Manufacturing Engineer applies advanced insight, experience, knowledge, skills, theory, principles, and analysis, as well as implements best practices and procedures, to technically support a complex range of Manufacturing Engineering activities. This role includes programming and troubleshooting machine control systems, with a focus on manufacturing equipment such as robotics, vision systems, and PLCs.

 

This role supports manufacturing processes to maintain and improve daily yield and equipment uptime, ensuring efficient and reliable operations. Additionally, the Senior Manufacturing Engineer regularly works with cross-functional teams, participates in continuous improvement projects, provides protocols and final reports, and leads various manufacturing activities.

 

The annual base salary range for this role is currently $125,000 to $145,000. This is a bonus-eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

 

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. 

Responsibilities

Key Accountabilities

• Modify and create PLC’s programs and automatic vision inspection camera systems based on given requirements and specifications
• Review, repair, and redesign legacy code preferred
• Troubleshoot issues with existing company installed systems
• Requirement Reviews - participate in reviews and work with automation outsoursing to ensure proper implementation of features
• Analyze manufacturing processes to identify issues, quality gaps, inefficiencies, and other opportunities to improve efficiency, quality, output, and technology. Drive process and product investigations Recommends and implements solutions to manufacturing problems
• Document new or revised manufacturing processes and procedures, change orders, and equipment specifications
• Own Non-Conformances and CAPAs
• Interpret mechanical design drawings for electrical requirements (e.g. SolidWorks)
• Research supplier products for assembly components
• Power up electrical systems and configure hardware per application specifications

Qualifications

Minimum Knowledge & Experience required for the position:

• Bachelor’s degree (Mechanical or Electrical Engineering) or equivalent years of experience; advanced degree a plus.
• Eight (8) to ten (10) years previous manufacturing engineering experience preferred; previous experience within a regulated medical device or pharmaceutical environment strongly preferred.

Skills & Capabilities:

• Six sigma green belt or black belt methodology a plus.
• Extensive knowledge/experience in process and product manufacturing.
• Excellent understanding of manufacturing, automation, and sustaining engineering concepts.
• Technically excellence in creating and understanding engineering drawings, schematics, specifications, tolerancing, and bills of materials (BOMs).
• Knowledge of PLC to implement changes to the program for automation and commercial robots, vision systems, injection molding hands on preferred, drying, label printing, pouching, packaging, and ultrasonic welding.
• In-Depth experience with automation development to be able to suggest proper design improvements.
• Excellent technical writing skills.
• Expertise in writing and performing validations in a GMP and ISO9001 regulated environment. This also includes URS/FAT for new equipment acquisition.
• Knowledge of statistical sampling and analysis including design of experiments (DOE) design.
• Proficiency in Solidworks.
• Understanding of Food and Drug Administration (FDA), Good Manufacturing Practices (GMP), ISO 9000 Standards, and Occupational Safety and Health Administration (OSHA) regulations; previous experience participating in regulatory audits preferred.
• Excellent written and verbal communication skills.
• Excellent equipment failures troubleshooting skills are required.
• Working knowledge of MS Office; knowledge of statistical software and large enterprise resource planning (ERP) system preferred.
• Excellent communication, organizational, and time management skills; ability to pay close attention to detail.
• Good leadership ability.

Travel requirements:

 

Able to travel to visit vendors processes.

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. 

 

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance.

 

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

 

www.werfen.com