Senior Manufacturing Test Development Engineer

Socket.dev; Bedford (MA); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with employer match

Paid vacation & sick leave

Commission plan for sales roles

Performance-based bonus

Job summary

Werfen seeks a Senior Manufacturing Test Engineer to design, develop, and validate automated test systems for critical electro-mechanical assemblies used in medical diagnostics. You will work across R&D and Manufacturing, applying rigorous engineering principles to deliver robust, scalable test solutions.

You will lead fixture design, test sequence development, and validation activities, while mentoring teammates and ensuring compliance with design controls and quality standards.

Qualifications

• Bachelor’s degree in Engineering, Science or a related field.
• Ten years of product development or relevant experience.
• In vitro medical device experience highly desired.
• English language proficiency required.

Responsibilities

• Design, develop, and validate automated manufacturing test systems for critical electro-mechanical assemblies.
• Create test fixtures from concept to hardware selection and system integration.
• Perform process validations (pFMEA, IQ, OQ, PQ, Gage R&R, DoE).
• Document activities and support design control.
• Mentor and guide team members and cross-functional teams.

Skills

TestStand

Python

LabVIEW

Electrical engineering

Data analysis

Root cause analysis

Mentorship

Communication

Automated systems

Education

Bachelor’s degree in Engineering, Science or related field

Tools

TestStand

Python

LabVIEW

Git

SVN

Perforce

Minitab

Job description

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 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.

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
• 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 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.
• Preferred: Experience in working in a regulated industry.

Qualifications

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 used in lieu of experience
• In vitro medical device experience highly desired.

Additional Skills/Knowledge:

• Language: Proficiency in English language required

International Mobility:

• Required: No

Travel Requirements:

• Some domestic and international travel may be required.

The annual base salary range for this role is currently $130K to $160K range. 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.

Closing

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.

www.werfen.com