Senior Manufacturing Test Development Engineer

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 7000 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. Were 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 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.

Minimum Knowledge & Experience Required for the Position:

Education:

• Bachelors 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 sales roles are eligible for participation in a commission plan and our managementand select professional rolesare eligible for a performance-based bonus.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals 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 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 7000 employees around the world comprise our Werfen team.