Senior Manufacturing Engineer

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 7000 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. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

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 $125000 to $145000. 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.

Key Accountabilities

• Modify and create PLCs 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

Minimum Knowledge & Experience required for the position:

• Bachelors 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.

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 individuals 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 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 7000 employees around the world comprise our Werfen team.