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.

Position Summary:

Under general supervision, is responsible for managing engineering activities and personnel for a defined program.  Defines processes, procedures and test methods across all projects within that program.  Directs and coordinates technical team members, and may act as a technical lead.  Using engineering procedures standard to research and development, carries out assignments associated with research, design, or development, and the manufacturing of specific parts and components of medical diagnostic systems.  Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making adaptations and modifications.  Plans and conducts work requiring the application of extensive and diversified knowledge of engineering principles in broad areas of assignments and related fields.  Generally uses advanced techniques and the modification or extension of theories, concepts and practices in the specialty and/or related disciplines.

Key Accountabilities: 

• Responsible for the functional management of a group of engineers within a given program. 
• Ensures that adequate personnel, equipment, and material resources are available to meet all project milestones within a program and can anticipate future needs for the program. 
• Supports the hiring process as needed. 
• Provides input to departments budget process.
• Responsible for yearly reviews of all direct reports. 
• Provides input to employee development and training procedures. 
• Provides input regarding training, coaching, and career development.
• Ensures that training records are up to date for all direct reports.
•   Provides technical support and identifies resources for Operations and Service requests for engineering support. 
• Generates schedules for engineering activities and reports program status. 
• Tracks metrics for assigned projects to monitor development time to aid in the creation of predictable schedules.
• Provides contingency plans for identified conflicts. 
• Prioritizes integration, development, verification and/or reliability activities to align with corporate goals and objectives. 
• Provides technical guidance to direct reports. 
• Act as a technical lead for a specific project. 
• Coordinates FMECA, FTA, traceability activities, requirements elicitation/review, integration testing, reliability activities, triage and verification activities across multiple projects for a given product line. 
• Provides technical support and identifies staff for root cause investigation activities in support of on-market complaint analysis. 
• Authors and/or reviews designs, tolerance studies, change requests, procedures, test methods, protocols and reports and assists in resolution of conflicting design requirements. 
• Authors and/or reviews project sub-plans, reviews requirements, risk management results, protocols, reports, architecture, and configuration management deliverables.  Assigns resources to and/or participates in CAPA investigations.
• Ensures that direct reports comply with engineering and design control processes. 
• Implements consistent methods and procedures.

Budget managed (if applicable) N/A

Internal Networking/Key relationships

• To be determined based on department needs

Skills & Capabilities: 

• Adapts to change quickly and is able to multi-task, managing several activities or projects simultaneously.
• Excellent communication and leadership skills are required.

Minimum Knowledge & Experience Required for the Position: 

• BA/BS with 8 years' experience or MS with 6 years' experience or equivalent combination of education and experience in Engineering, Science or related field, (Biology, Chemistry, Physics, Biotechnology, Biomedical, Electrical, Mechanical, Chemical Engineering).
• In-vitro medical device experience highly desired. 
• Minimum of 3 years functional management or supervisor experience.
• Minimum of 6 years product development experience.
• Strong knowledge of engineering theories and practices with the ability to effectively incorporate these practices.

International Mobility: Required: yes

Travel Requirements: 

• Some domestic and international travel my be required