Principal Engineer

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.

Position Summary: Using engineering procedures standard for research and development, the candidate carries out assignments associated with research, design, development, support, or manufacturing of specific parts, processes, software or components of medical diagnostic systems. The role independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. It plans and conducts work requiring the application of extensive and diversified knowledge of engineering principles in broad areas.

Generally, it uses advanced techniques and the modification or extension of theories, concepts and practices in the specialty and/or related disciplines. The individual maintains a clear overview of a major product development, makes sound judgments when compromises are necessitated, mentors junior staff, and acts as a technical lead for specific project or product lines.

Key Accountabilities:

Essential Functions:

• Acts as an individual contributor, core team, or technical lead for a specific project or product line.
• 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, and prioritizes tasks that are complex in nature, in alignment with corporate goals.
• Analyzes and interprets data, identifying trends and formulating next steps, while effectively performing trade‑off analysis when required by the function.
• Leads, designs, and/or develops new test methods, specifications, technical apparatus, software, and processes for complex components and functions.
• Evaluates complex designs or processes, with respect to acceptability, suitability, and cost, recommends preferred design options, and presents trade‑off when required.
• Identifies product defects, recognizes outliers in results, explains and documents product defects and their impact.
• Communicates technical information to a multidisciplinary team in the form of documentation, presentations, and technical summaries, promoting collaboration.
• Possesses technical expertise in more than one area or is a subject‑matter expert in at least one area.
• Leads without authority, provides technical guidance to engineers and technicians assigned to them on a given project, and provides mentoring within or outside their department.
• Provides technical support for or leads CAPA or complaint investigations.
• Independently generates predictable schedules for activities related to the function, understanding cross‑functional dependencies.

Secondary Functions:

• May review and provide input to deliverables from other functions.
• Recommends and drives improvement initiatives and motivates others to implement.
• May be assigned CAPA ownership.

Budget Managed: N/A

Skills & Capabilities:

• Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical Thinking
• Technically adept and confident
• Leadership:
  Accountability, Decision Making, Influence, Communication
• Mentoring

Minimum Knowledge & Experience

Required:

Education:

• Bachelor's degree in Engineering, Science, or a related field.

Experience:

• Twelve years of product development or relevant experience.
• Eight to ten years of product development or relevant experience for advanced degrees.
• For internal candidate promotion:
  Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience.
• In vitro…