Senior Process Engineer

Werfen•Bedford, MA

1d•$110,000 - $140,000•Onsite

About The Position

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: We are seeking a Senior Process Engineer with strong expertise in test system development, LabVIEW programming, and mechanical engineering within a regulated medical device environment. Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific part, 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.

Requirements

Bachelor's degree in Engineering, Science or a related field
Eight years of product development or relevant experience
Four to six years of product development or relevant experience for advanced degrees
Proficiency in English language required
Expertise in Teststand, LabVIEW and Python programming and automated test system development.
Experience with data acquisition systems, instrumentation, and hardware integration.
Knowledge of validation methodologies and regulated environments.
Excellent problem-solving, analytical, and technical documentation skills.
Solid foundation in mechanical engineering design and analysis.
Technically adept and confident.
Leadership: Accountability, Decision Making, Influence, Communication.

Nice To Haves

In vitro medical device experience highly desired.

Responsibilities

Develop and implement automated test systems for product verification and validation.
Design and build custom fixtures, tooling, and test setups to support engineering and production needs.
Design, develop, and maintain Teststand, Python and LabVIEW-based applications for data acquisition, control systems, and automated testing.
Integrate hardware components (sensors, DAQ systems, instrumentation) with software platforms.
Apply mechanical engineering principles to design and improve test equipment, fixtures, and manufacturing processes.
Create and review engineering drawings, CAD models, and specifications.
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.
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.
Lead the development and optimization of manufacturing and validation processes.