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Werfen · 5 hours ago

Senior Process Engineer

US-MA-Bedford

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Werfen is a growing, family-owned, innovative company that specializes in diagnostics in various medical fields. The Senior Process Engineer is responsible for developing and implementing test processes for manufacturing critical assemblies in medical diagnostic systems, collaborating closely with R&D and manufacturing teams.

Health CareHospitalManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Leads and develops new test methods for manufacturing, including but not limited to:

Defining specifications

Designing & procuring fixtures

Outsourcing fixtures and management of supplier deliverables

Controlling hardware with LabVIEW and/or TestStand

Automation and motion control

Communicating with databases

Optimizing processes conditions

Fixture design

Executes process validations, including but not limited to: pFMECA, IQ, OQ, PQ, gauge R&R, DoE, process capability

Accountable for the completion of assigned deliverables in accordance with approved schedules

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

Leads, designs and/or develops one or more of the following: new test methods, specifications, technical apparatus, software and processes for moderately complex components and functions

Identifies product defects and recognizes outliers in results. Can explain and document product defects and their impact

Effectively communicates complex technical information to a cross-functional team in the form of documentation, presentations or technical summaries

Provides technical guidance to and/or supervision of other group members and cross-functional technical teams. Able to mentor others

Provides technical support for or leads investigations in support of development and/or on-market activities

Independently generates predictable schedules for activities related to assigned projects

May review and provide input to deliverables from other functions

Independently generates predictable schedules for activities related to assigned projects

Provides technical guidance to and/or supervision of other group members and cross-functional technical teams. Able to mentor others

Recommends and implements improvement initiatives to aid department practices

Qualification

LabVIEWTestStandTest fixture developmentProcess validationElectrical engineeringElectro-mechanical systemsStatistical analysisRobotic systemsMinitabCAD designPythonCreative problem solvingCritical thinkingMentoringTeamworkCommunication skills

Required

Bachelor's degree in Engineering, Science or a related field

Eight years of product development or relevant experience

Four to six years of product development or relevant experience for advanced degrees

Proficiency in English language required

Strong in LabVIEW and TestStand

In vitro medical device experience highly desired

Preferred

Process validation

CAD design (Creo preferred)

Familiarity with Python

Company

Werfen

Glassdoor4.0

Werfen is a developer, manufacturer and distributer of IVD testing solutions.

Founded in 1966

Barcelona, Catalonia, ESP

5001-10000 employees

http://www.werfen.com/

H1B Sponsorship

Werfen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (10)

2024 (12)

2023 (10)

2022 (2)

2021 (11)

2020 (8)