Senior Engineering Group Leader - Process Engineering

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.

Position Summary:

Reporting to the Functional Manager, responsible for assigning and overseeing the practical use of technology across multiple programs assuring the proper use of common architecture. Receives requirements specifications from the Project Managers and prepares specifications to design, develop or integrate technologies required to make a product and its specific derivatives. Responsible for all Functional Specifications and Theory of Operation documents, including schematics, design layouts, detail and assembly drawings, bill of materials, associated analytical data and any implementation documents.

May act as group leader or lead engineer on a major program, perform independent development, and be responsible for a number of smaller projects.

• Oversees the shared application of technology across programs in area of expertise.
• Performs design reviews to ensure that designs are reliable and meet cost targets, product requirements and all safety standards; presents findings and implements solutions.
• Performs all required engineering analysis of characteristics of the system being designed.
• Ensures the proper access and availability of required development tools.
• Oversees the proper implementation of required documentation and archiving as defined by corporate compliance agreements.
• Manages and supervises team consisting of engineers and technicians as required.
• Produces realistic schedules that are consistent with phased delivery requirements.
• Ensures availability of relevant resources to programs and anticipate future needs.
• Coordinates and integrates development efforts with other technical groups.
• Responds to changes in the scope of projects and impact on delivery time/functionality.
• Identifies capital equipment requirements for immediate and budgetary considerations.
• Responsible for yearly review of section personnel and recommends proper training.
• Controls change orders.
• Reviews manufacturability, reliability and serviceability analysis and offers cost reduction design and recommendation.
• Assures designs meet reliability engineering requirements.
• Participates in call rate reduction.

• Bachelor’s degree in ME/EE/System Engineering (or equivalent) with a minimum of 15 years of product development experience, or a BS and MS in Engineering discipline with at least 10 years of experience.
• Collaborate with Product Design & Analytical Groups to ensure designs incorporate DFM techniques.
• Risk Assessment:
  Create and maintain PFMECA’s & Process Impact Analysis (PIA);
  Contribute to DfMECA as required for new product introduction and supplement determination of critical to quality (CTQ) components; develop control plans and inspection routings.
• Develop or select test automation & equipment:
  Lead proof of concept demonstration of robust and novel test & automation solutions, and identify/develop equipment required for product manufacture.
• Process Development:
  Develop new manufacturing processes employing Six Sigma methodologies;
  Create documentation framework for new materials, assemblies, and processes;
  Develop floor plans, facility requirements, set up preliminary operations area or pilot lab test area.
• Process Validation:
  Validate new processes implementing statistical…