Senior Manufacturing Test Engineer II

Werfen; Bedford (MA); Presencial; USD 145.000 - 175.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, and vision insurance

401k with employer match

Paid vacation and sick leave

Descripción de la vacante

Werfen, Bedford, MA, is seeking a Senior Manufacturing Test Engineer to design, develop, and validate automated test systems for electromechanical medical diagnostic instruments. You will manage full fixture life cycles, support R&D and Quality, and implement robust, scalable test solutions.

You will lead test development, perform process validations (IQ/OQ/PQ), and mentor team members while collaborating across functions to ensure quality and efficiency in manufacturing.

Formación

• B.S. in Engineering with 12+ years of product development experience or an M.S. with at least 8 years of experience.
• Experience providing technical support for the manufacture of instrumentation or disposables preferred.
• Lean and Six Sigma problem solving methodologies experience preferred.

Responsabilidades

• Lead and develop new test methods for manufacturing.
• Define specifications and design/procure fixtures.
• Champion design for test to improve testability.
• Outsource fixtures and manage supplier deliverables.

Conocimientos

TestStand

Python

LabVIEW

Version control

Electro-mechanical systems

Root cause analysis

Data analysis

Robotics/automation experience

Regulated industry experience

Educación

B.S. in Engineering

M.S. in Engineering

Herramientas

TestStand

Python

LabVIEW

Git/SVN/Perforce

Descripción del empleo

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

Country

United States

Shift

1st

About the Position

Introduction

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.

Overview

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.

Responsibilities

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 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 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 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.


• 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.

Qualifications

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: 5% of time

The annual base salary range for this role is currently $145,000 to $175,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.