Senior Manufacturing Test Development Engineer

Senior Manufacturing Test Development Engineer

Werfen - Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

1st

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:

The Senior Manufacturing Test Engineer is responsible for designing, developing, and validating automated manufacturing test systems for critical electro-mechanical assemblies used in medical diagnostic products. This includes all aspects of test fixture development, from conceptual design and hardware selection to system integration, software controls, documentation, and validation. The position works cross-functionally with R&D and Manufacturing throughout the product lifecycle and independently applies engineering principles, techniques, and judgment to deliver robust, scalable test solutions.

Key Accountabilities:

• Leads and develops new test methods for manufacturing, including but not limited to:
• Defining specifications
• Designing & procuring fixtures
• Champion design for test (DfT) to improve testability of the device
• Outsourcing fixtures and management of supplier deliverables
• Test sequence development and debugging using Test Stand, LabVIEW, or equivalent
• Communicating with databases
• Executes process validations, including but not limited to: pFMEA, IQ, OQ, PQ, Gage R&R, DoE, process capability
• 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.
• Demonstrated experience performing root cause analysis (RCA) and driving corrective actions.
• Effectively communicates complex technical information to a cross-functional team in the form of documentation, presentations, or technical summaries.
• Provides mentorship and technical guidance to other group members and cross-functional technical teams.

Secondary Functions:

• Perform documentation and provide design reviews
• May review and provide input to deliverables from other functions.
• Independently generates predictable schedules for activities related to assigned projects.
• Recommends and implements improvement initiatives to aid department practices.
• Experience managing and collaborating with vendors and Contract Manufacturers (CMs)

Skills & Capabilities:

• Proficiency in scripting and programming using Test Stand, Python, and LabVIEW.
• Proficiency in version control systems such as Git, SVN, or Perforce.
• Statistical Analysis, Root Cause Analysis, Creative Problem Solving, Critical Thinking
• Solid working knowledge of basic electrical equipment, including digital multimeters, oscilloscopes, and power supplies.
• Strong understanding of electro-mechanical systems.
• General knowledge of statistics, working knowledge of Minitab
• Strong verbal and written communication skills
• Capable of highly self-motivated with the ability to resolve complex problems independently and collaboratively within a team environment. Experience in robotic or automated systems.
• Preferred:
  Experience in working in a regulated industry.

Minimum Knowledge & Experience Required for the Position:

Education:

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

Experience:

• Ten years of product development or relevant experience
• Six to eight 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…