Senior Process Engineer

About the Position

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.

Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Under the general direction of a functional manager, with moderate latitude for self-direction, operates in one or more areas of responsibility within a specific function.

This Senior Engineer in the Process Development Engineering group is responsible for developing and implementing test processes for the manufacture of critical assemblies in medical diagnostic systems that are electro‑mechanical in nature. Create complex automated test fixtures, from conceptual design to hardware selection & integration as well as software control systems, documentation, and validation with heavy focus on LabVIEW and Test Stand development.

Collaborate closely with both R&D and manufacturing across all phases of development. Independently evaluate, select, and apply standard engineering techniques, procedures, and criteria.

Key Accountabilities:

• Leads and develops new test methods for manufacturing, including but not limited to:
  • Defining specifications
  • Designing & procuring fixtures
  • Outsourcing fixtures and management of supplier deliverables
  • Controlling hardware with LabVIEW and/or Test Stand
  • Automation and motion control
  • Communicating with databases
  • Optimizing process conditions
  • Fixture design
  • Executes process validations, including but not limited to: pFMECA, IQ, OQ, PQ, gauge R&R, DoE, process capability
  • Accountable for the completion of assigned deliverables in accordance with approved schedules.
  • Authors documentation and participates in activities in support of design control
  • Independently plans, performs & prioritizes tasks that are moderately complex in nature, in alignment with corporate goals.
  • Analyzes and interprets data, identifying trends and formulating the next steps, if required by the function.
  • Leads, designs and/or develops one or more of the following: new test methods, specifications, technical apparatus, software and processes for moderately complex components and functions.
  • Identifies product defects and recognizes outliers in results. Can explain and document product defects and their impact.
  • Effectively communicates complex technical information to a cross‑functional team in the form of documentation, presentations or technical summaries.
  • Provides technical guidance to and/or supervision of other group members and cross‑functional technical teams. Able to mentor others.
  • Provides technical support for or leads investigations in support of development and/or on‑market activities.
  • Independently generates predictable schedules for activities related to assigned projects.

Secondary Functions:

• May review and provide input to deliverables from other functions.
• Independently generates predictable schedules for activities related to assigned projects.
• Provides technical guidance to and/or supervision of other group members and cross‑functional technical teams. Able to mentor…