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Process Development Engineer III

Process Development Engineer III

WerfenBedford, MA, United States
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Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States.Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specia...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Contract Associate Engineer, Upstream Process Development

Contract Associate Engineer, Upstream Process Development

Beacon Hill Life Sciences - BostonBedford, MA, US
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The Associate Engineer will help drive the development of our client’s Gene Therapy platform.Working as a member of Gene Therapy Process Development Group within the Technical Operations Depa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Senior Process Engineer

Senior Process Engineer

EmvolonWoburn, MA, US
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MIT spin-off on a mission to convert greenhouse gas emissions into carbon-negative fuels and chemicals like green methanol and green ammonia. Leveraging our patented technology, we transform car eng...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Process Engineer

Process Engineer

RIT SolutionsCambridge, MA, US
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REAL Process Engineer who has legitimate experience with formulations of liquid suspensions and oral solid dosage processes? Seeking a TRUE PROCESS ENGINEER. MUST HAVE experience with formulations o...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Adjunct Faculty - Process Development

Adjunct Faculty - Process Development

MCPHS UniversityBoston, MA, US
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Adjunct Instructor For Biomanufacturing Process Development.The School of Professional Studies is seeking an adjunct instructor to develop and teach a new course in Biomanufacturing Process Develop...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Avionics Process Engineer

Avionics Process Engineer

MerlinBoston, MA, US
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Engineering Systems Engineering / Full Time / On-site.About Merlin : Merlin is a venture backed aerospace startup building a non-human pilot to enable both reduced crew and uncrewed flight.Backed b...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Microfabrication Process Engineer

Microfabrication Process Engineer

Draper LabsCambridge, MA, United States
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Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Manufacturing Process Engineer

Manufacturing Process Engineer

Katalyst Healthcares & Life SciencesWaltham, MA, US
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Responsibilities : Lead projects in manufacturing process areas to achieve process efficiencies such as increase in process yield, quality improvements, cycle time / throughput, and cost reduction ini...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Process Engineer ll

Process Engineer ll

Sublime SystemsSomerville, MA, US
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Sublime is advancing a breakthrough, clean, efficient, low-waste process for manufacturing cement, the essential ingredient in the most-consumed human-made material on Earth : concrete.Replacing 200...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Process Engineer

Process Engineer

E-SolutionsCambridge, MA, US
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Job Location : Cambridge, MA (Onsite).Minimum years of experience in Product Industrialization Engineering.serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Process Engineer

Process Engineer

MaterionNewton, MA, US
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At Materion, everyone is included, respected and offered opportunity to grow.Ensures that all processes accurately reflect the production practices, costing is adequate and quality requirements mee...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Engineer : Process Improvement Engineer

Engineer : Process Improvement Engineer

NanobiosymCambridge, MA, US
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Nanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery.Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Process Engineer I

Process Engineer I

CuraleafBoston, MA, US
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At Curaleaf, we're redefining the cannabis industry with a strong commitment to quality, expertise, and innovation.As a leading global cannabis provider, our brands—including Curaleaf, Se...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Process Development Engineer

Process Development Engineer

SSi PeopleCambridge / Massachusetts
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Job Title : Process Development Engineer.We are seeking a Process Development Engineer to support the transfer and optimization of purification processes for biologics drug substance manufacturing.I...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Sr. Process Development Engineer I

Sr. Process Development Engineer I

KCO Resource ManagementBoston, MA
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Process Development Engineer I.Process Development Engineer to join a food & beverage research & development team.This individual will work closely with product development scientists to advance ne...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Process Engineer II

Process Engineer II

Lantheus BrandBedford, MA, US
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Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden.For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has help...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Lead Process Engineer

Lead Process Engineer

Verdox, IncWoburn, MA, US
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Verdox is dedicated to reversing climate change through the development and deployment of advanced technology.Our proprietary electro-swing process, developed at MIT, enables carbon dioxide and oth...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Process Development Associate

Process Development Associate

ArborCambridge, MA, US
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Arbor Biotechnologies, a next-generation gene editing company based in Cambridge, MA, is advancing a pipeline of novel gene editing therapeutics to address a wide range of genetic conditions from ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Senior Engineer II, Pharmaceutical Development, Process Development

Senior Engineer II, Pharmaceutical Development, Process Development

Elektrofi IncBoston, MA, US
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Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines.Our breakthrough ultra-hi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Principal Process Development Engineer

Principal Process Development Engineer

OrbiaBoston, US
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Ready to stretch your potential.That’s the spirit of the community you will find at Orbia : where the purpose to advance life around the world drives our global team of over 23,000 every single day....serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Process Development Engineer III

Process Development Engineer III

WerfenBedford, MA, United States
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Job Information

Number

ICIMS-2025-8856

Job function

Job type

Full-time

Location

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

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

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.

Position Summary :

Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Under the general direction of senior engineering personnel, with moderate latitude for self-direction, operates in one or more areas of responsibility within a specific Function.

Responsibilities

This role will be the lead Process Development Engineer for new product development on the ROTEM delta and sigma products, which perform viscoelastic testing on whole blood. Process Development Engineering is the functional group within R&D Hardware Engineering that is responsible for design transfer (developing and implementing assembly and test processes in manufacturing). Major areas of focus are standard operating procedures, process validation, risk analysis, fixture design, and process optimization. Key Accountabilities

  • Acts as an individual contributor, core team or technical lead for a specific project.
  • 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.
  • Leads and develops processes for manufacturing, including but not limited to :

Defining requirements for fixtures and processes

  • Outsourcing fixtures and managing supplier deliverables
  • Creating, documenting, and executing tests
  • Mapping process limits and capabilities
  • Advise on Design for Manufacturability, Assembly, Test (DFM, DFA, DFT)
  • Create and modify standard operating procedures (SOPs)
  • Identifies product defects and recognizes outliers in results. Can explain and document product defects and their impact.
  • Executes process validations, including but not limited to : IQ, OQ, PQ, GR&R / MSA, process SW validations, spreadsheet validations
  • Analyze risks : design change risk assessments, pFMEA / pFMECA
  • Effectively communicates complex technical information to a cross-functional team in the form of documentation, presentations or technical summaries.
  • Provides technical support for and / or leads investigations in support of development and / or on-market activities.
  • Generates predictable schedules for activities related to assigned projects.
  • Secondary Functions :

  • May provide limited technical guidance and / or supervision of other group members.
  • Recommends improvement initiatives to aid department practices.
  • Budget Managed (if applicable)

  • N / A
  • Internal Networking / Key Relationships

  • Highly cross-functional : regular interface with other groups within R&D (Hardware, Analytical, Project Management, SW), Manufacturing, Operations
  • Assist with R&D management for project-specific planning
  • Skills & Capabilities :

  • Statistical analysis, root cause analysiscreative problem solving
  • Technical expertise in at least 1 area
  • Technical leadership : accountability, decisionmaking, influence
  • Strong teamwork, organization, and communication skills
  • Detailed documentation
  • Desired : CAD design (Creo preferred), optics knowledge, hardware integration with SW / firmware
  • Qualifications

    Minimum Knowledge & Experience Required for the Position :

    Education :

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

  • Five years of product development or relevant experience
  • One to three 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.
  • 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 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 NAtalentacquisition@werfen.com 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

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