Senior Manufacturing & Project Engineer Operational Excellence

Overview

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.

Job Summary

This role requires a combination of Senior Engineer & Project Manager accountabilities, responsibilities, and capabilities. As a Sr. Manufacturing Engineer, one will apply advanced knowledge of engineering principles and analyses to support a complex range of Manufacturing Engineering activities, including solving multifaceted issues related to product design and manufacturing processes, new and existing processes, product improvement, and supporting daily production operations. As a Project Manager, one will plan and manage multi-functional product improvement efforts, product transfer projects, continuous improvement, and/or several sub-projects within a large, Global program.

The position requires strong leadership skills in a highly technical medical instrument environment, as well as regular interaction with scientists, hardware engineers, software engineers, technicians, marketing/sales, quality, manufacturing, suppliers, administrative personnel, and senior management.   Requires confidence to lead strong technical engineers and scientists in a dynamic, interactive, and energetic workplace. Directs the project team in a manner to achieve the business results expected.

Responsibilities

Key Accountabilities

• Technical Leadership: Provide technical and team leadership to one or more cross-functional project teams, ensure design requirements are met and comply with applicable standards.
• Problem Solving Leadership: Responsible for coordination of technical resources to identify the root cause of any project issue, and develop and manage a plan to fix, test, and implement an appropriate solution through completion.
• Risk Management: Responsible for ensuring project risks, both technical risks and management risks, are identified and appropriately addressed within the project plan. Develop risk mitigation plans.
• Project Planning and Scheduling: Work as a lead project team member to complete all activities needed to conclude projects per plans. Responsible for project planning and scheduling, clarifying and defining scope of work and project specifications. Utilize deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing tasks to meet business objectives.
• Develop and implement process controls for product transfer to manufacturing, or to new manufacturing site.
• Project Execution and Control: Responsible for conducting regular project team status meetings and reviews.  Oversee validation project teams; prepare agendas, issue meeting minutes, and participate in development of quality plans. Ensures deliverables are completed and documented.
• Design Control: Write, review, and approve validations (installation qualification IQ/operational qualification OQ/performance qualification PQ protocols, Standard Operating Procedures (SOP), technical reports and final reports) for new products, processes, and equipment.
• Ensure all projects/processes are following FDA, Good Manufacturing Practices (GMP), Quality System Requirement (QSR), ISO-13485:2003 and other applicable requirements.
• Identify and implement opportunities for continuous improvement.
• Communication: Responsible for project communication to both the project team and executive management.
• Resource Allocation: Ensures that adequate equipment and material resources are available to advance the project and achieve goals and objectives.
• Conflict Resolution: Able to resolve project team conflict through the application of good listening skills and negotiating skills.

Qualifications

Minimum Knowledge & Experience for the position:

• Bachelor’s degree in engineering; advanced degree a plus.
• Eight (8) years previous manufacturing engineering experience preferred.
• Previous experience within a regulated medical device or pharmaceutical environment
• Requires full and comprehensive knowledge of the complete product lifecycle, including all aspects of product development from conception to manufacturing introduction.
• Experience in the development and release of at least one successful product launch of a medical instrumentation product is desirable.
• Product development experience, including three years in successful technical leadership, project coordination, or project management are required.

Skills & Capabilities:

• Six sigma green belt or black belt methodology a plus.
• Extensive knowledge/experience in process and product manufacturing.
• Experience in creating and understanding engineering drawings, schematics, specifications, tolerancing, and bills of materials (BOMs).
• In-Depth experience with automation development to be able to suggest proper design improvements.
• Expertise in writing and performing validations in a regulated environment.
• Knowledge of statistical sampling and analysis
• 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 organizational and time management skills; attention to detail.

Travel requirements:

Approximently 20%. International Mobility required

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 NAtalentacquisition@werfen.com for assistance.

www.werfen.com