Senior Manufacturing Test Development Engineer

Werfen•Bedford, MA

2d•$130,000 - $160,000•Onsite

About The Position

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.

Requirements

Bachelor's degree in Engineering, Science or a related field
Ten years of product development or relevant experience
Six to eight years of product development or relevant experience for advanced degrees
Proficiency in scripting and programming using TestStand, 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.
Proficiency in English language required

Nice To Haves

In vitro medical device experience highly desired.
Experience in working in a regulated industry.

Responsibilities

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 TestStand, 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.
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)