Manufacturing Engineer II

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 Manufacturing Engineer II applies knowledge, skills, and best practices to support a high-visibility manufacturing readiness and manufacturing transfer initiative with an accelerated implementation timeline. The role is responsible for developing and maintaining ERP (SAP) product structures, including BOMs, material masters, part numbers, and routings, while creating and standardizing manufacturing documentation such as Device Master Records (DMRs), process flow diagrams, and quality release requirements. The Manufacturing Engineer II executes label validation and verification activities to ensure compliance and manufacturing readiness, and partners cross-functionally with Quality, Operations, Supply Chain, and Engineering teams to support successful transfer execution. The position also identifies and mitigates manufacturing transfer risks while driving achievement of key project milestones.

 

This will be a contract position from August 2026 - January 2027, with possibility of extension depending on business needs. 

 

The salary range for this role is currently $80,000 to $100,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

 

Responsibilities

Key Accountabilities

• Participate in design reviews for new product design and development; ensure designs meet requirement specifications.
• Review all product documentations and ensure design manufacturability. 
• Design and develop manufacturing plan, processes, testers, fixtures, and equipment. 
• Participate in vendor and supplier qualification processes; ensure capability to meet company's quality standards, technical requirement specifications, and supply demand.
• Support installation, qualification, and validation of new equipment and processes; write and execute feasibilities, protocols/reports, and standard operating procedures (SOPs).  Provide troubleshooting and failure analysis.
• Create/implement programs for volume demand increases, cost reduction, quality, and efficiency improvement. 
• Resolve technical issues with vendors and suppliers. 
• Resolve electronic parts obsolescence and Restrictions on Hazardous Substances (RoHS) / Waste of Electrical and Electronic Equipment (WEEE) component engineering issues; drive and coordinate activities to make all active manufactured instruments RoHS/WEEE compliant (Electrical Engineer specific).  
• Establish a safe, secure, controlled and efficient operating environment. 
• Prepare reports as needed.
• Advance knowledge of scientific and engineering principles. 
• Ensure and maintain compliance with the company's quality system requirements through training and adherence to policies, procedures and processes. 
• Other duties as assigned.

Qualifications

Education/Experience:

• Bachelor's degree (Mechanical or Electrical Engineering) or equivalent years of experience. 
• Three (3) to five (5) year previous manufacturing engineering experience; previous experience within a regulated medical device or pharmaceutical environment preferred. 
• Good understanding of manufacturing, automation, and sustaining engineering concepts. 
• Technically proficient in creating and understanding engineering drawings, schematics, specifications, tolerancing, and bills of materials (BOMs). 
• Knowledge of PLC, vision, reagent filling/dispensing, injection molding, drying, printing, pouching, and packaging preferred. 
• Experience with automation development (batch and continuous methods). 
• Good technical writing skills. 
• Competent in writing and performing validations in a GMP and ISO9001 regulated environment; statistical analysis and sampling experience preferred. 
• Proficiency in Solidworks or CAD. 
• Familiarity with Food and Drug Administration (FDA), Good Manufacturing Practices (GMP), ISO 9000 Standards, and Occupational Safety and Health Administration (OSHA) regulations. 
• Good written and verbal communication skills. 
• Excellent problem solving skills are required 
• Working knowledge of MS Office. 
• Good communication, organizational, and time management skills; ability to pay close attention to detail. 
• Ability to work as part of a team. 
• Ability to identify and correct problems.

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