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Senior Engineer

Werfen

Bedford, MAOnsitePosted 4 days ago
Full TimeSenior LevelManufacturing & CMCDiagnostics
Original posting ↗

Summary

In this Laboratory Automation Systems Engineering role, the applicant will generate and manage testable system requirements, manage a risk database based on patient safety, and oversee integration, verification, and validation activities while interacting on a cross-functional team.

Job description

Position Summary

In this Laboratory Automation Systems Engineering role, the applicant will generate and manage testable system requirements, manage a risk database based on patient safety, and oversee integration, verification, and validation activities while interacting on a cross-functional team.

Key Accountabilities

  • Experience working in Laboratory Automation for medical devices
  • Experience running verification projects, including managing system requirements and product risk
  • Experience working in a Linux-based operating system
  • Acts as an individual contributor, core team or technical lead for a specific project
  • Accountable for 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 moderately complex tasks in alignment with corporate goals
  • Analyzes and interprets data, identifying trends and formulating next steps
  • Leads, designs and/or develops new test methods, specifications, technical apparatus, software and processes for moderately complex components and functions
  • Identifies product defects and recognizes outliers in results; explains and documents product defects and their impact
  • Effectively communicates complex technical information to a cross-functional team via documentation, presentations or technical summaries
  • Technical expertise in at least one area
  • 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

Nice to Have

  • Experience coding in one or more languages
  • Experience with computer networking

Minimum Knowledge & Experience Required

  • 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
  • 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 medical device experience highly desired
  • Proficiency in English language required
  • Some domestic and international travel may be required

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
  • Experience working in Laboratory Automation for medical devices
  • Experience running verification projects, including managing system requirements and product risk
  • Experience working in a Linux-based operating system
  • Proficiency in English language required
  • In vitro medical device experience highly desired
  • Experience coding in one or more languages
  • Experience with computer networking

Company overview

Werfen is a global leader in specialized diagnostics, founded in 1966 in Barcelona, Spain as a family-owned innovative company. The organization has established itself as a worldwide authority in five key clinical areas: Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant diagnostics. With headquarters in Barcelona and technology centers strategically located in the United States and Europe, Werfen operates directly in 30 countries and serves more than 100 territories through distributors. The company achieved remarkable financial performance with worldwide sales exceeding €2.2 billion in 2024, supported by a workforce of over 7,000 employees globally. Werfen's comprehensive portfolio includes advanced diagnostic systems, reagents, laboratory automation solutions, and point-of-care testing platforms that enable healthcare providers to deliver precise and timely patient care. Their innovative technologies span from blood gas analyzers with hemolysis detection capabilities to automated immunoassay systems and specialized diagnostic assays. As a vertically integrated diagnostics company, Werfen maintains complete control over research, development, manufacturing, and distribution, ensuring quality and reliability across their product lines while continuously advancing diagnostic science to address critical healthcare challenges worldwide.

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