Senior Manufacturing Test Engineer II

Position Summary

The Senior Manufacturing Test Engineer is responsible for designing, developing, and validating automated manufacturing test systems for on-market electromechanical assemblies and instruments used in medical diagnostic products. The role encompasses the full lifecycle of test fixture development, from conceptual design and hardware selection through system integration, software controls, documentation, and validation. Reporting to the Operations Director, the Senior Manufacturing Test Engineer collaborates cross-functionally with R&D, Quality and Manufacturing throughout the product lifecycle and independently applies engineering principles, technical expertise, and sound judgment to deliver robust, reliable, and 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 and risk assessment
• Independently plans, performs & prioritizes tasks that are moderately complex in nature, in alignment with production 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.
• Expertise in test fixture development
• Strong foundation in electrical engineering concepts
• 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;
  In Vitro Diagnostics/Medical Device experience highly desired.

Minimum Knowledge & Experience required for the position:

• B.S. in Engineering and a minimum of 12 years of experience in product development or an M.S. Degree and at least 8 years of experience in product development
• Experience in technical support for the manufacturing of instrumentation and/or disposables preferred
• Experience in Lean and Six Sigma problem solving methodologies preferred

Skills & Capabilities:

• Functional/technical skills

Travel requirements: