FDA Jobs in Boston, MA

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Engineer III, Validation

Thermo Fisher Scientific

•

Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 24 days ago | Updated 8 hours ago

Lead Mechanical Engineer

Motion Recruitment Partners, LLC

•

Boston, Massachusetts, USA

Full-time

Our client, an innovative diagnostic medical device company, is seeking a Lead Mechanical Engineer to join their team. This individual will play a critical role in leading the design, development, and refinement of mechanical systems for next-generation diagnostic products. The company is committed to transforming point-of-care diagnostics and is looking for someone who thrives in a collaborative, fast-paced environment. This is an excellent opportunity for an experienced mechanical engineer who
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Posted 41 days ago | Updated 4 hours ago

Principal Validation Engineer

Johnson & Johnson

•

Danvers, Massachusetts, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 45 days ago | Updated 8 hours ago

Associate Director, Human Factors & Usability Engineering

Sanofi U.S.

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Cambridge, Massachusetts, USA

Full-time

Job title: Associate Director, Human Factors & Usability Engineering Location: Cambridge, MA, Morristown, NJ About the job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. At Sanofi, we chase the miracles of science to improve people's liv
Posted 11 days ago | Updated 8 hours ago

Senior C++ QT Software Engineer - Med Device

Motion Recruitment Partners, LLC

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Marlborough, Massachusetts, USA

Full-time

Our client, a leading innovator in the medical device industry, is seeking a Senior Software Engineer with strong expertise in C++, Qt, and image processing/computer vision. This role offers the opportunity to contribute to advanced diagnostic and imaging solutions that have a real impact on patient care. Key Responsibilities: Design, develop, and maintain software applications using C++ and the Qt frameworkImplement and optimize algorithms for image processing and computer visionCollaborate wit
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Posted 31 days ago | Updated 4 hours ago

Automation Engineer

Katalyst Healthcares and Lifesciences

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Framingham, Massachusetts, USA

Full-time

Roles & Responsibilities: Lead design, configuration, and commissioning of DeltaV and Client-X automation systems for GMP-critical manufacturing equipment and process controls. Support change controls, deviations, and CAPAs involving DeltaV and Client-X logic, batch strategies, and alarm configuration in collaboration with QA and Validation. Develop and modify control modules, phases, and equipment modules within DeltaV in alignment with S88 batch architecture standards. Provide hands-on trouble
Posted 45 days ago | Updated 8 hours ago

Site Compliance Quality Head

Software Guidance & Assistance

•

Billerica, Massachusetts, USA

Full-time

Software Guidance & Assistance, Inc., (SGA), is searching for a Site Compliance Quality Head for a FULL-TIME assignment with one of our premier Pharmaceutical Services clients in Billerica, MA. Responsibilities: Implement and manage the records in electronic Quality Systems, such as QMS, EDMS, and LMS, etc. providing procedures and training for employees to effectively use the electronic Quality Systems Supervise the QA Documentation department in the creation, issuance, maintenance, archivi
Posted 15 days ago | Updated 6 hours ago

Staff UX Designer

Motion Recruitment Partners, LLC

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Boston, Massachusetts, USA

Full-time

We are a rapidly growing SaaS company serving the life sciences and biotechnology sector, helping research organizations accelerate innovation by transforming raw scientific data into AI-ready assets. Our platform is designed to support complex scientific workflows while meeting the highest standards of data integrity, usability, and compliance. We are seeking an experienced Staff UX Designer to lead the strategic design of user experiences that drive meaningful engagement and scientific impact.
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Posted 43 days ago | Updated 4 hours ago

Software Engineer - Embedded C, C#, C++ | Marlborough, MA

Michael Page International

•

Marlborough, Massachusetts, USA

Full-time

Join a revolutionary medical device manufacturing organizationWork with a team making a difference to patients all over the world About Our Client The company is a medical device organization that design and develop cutting-edge software for complex medical devices. They have an FDA approved device that is live in the US, Europe & Asia and they're looking to further grow their R&D team with this hire, and plan to continue their growth for the remainder of 2025 and into 2026! Job Description
Posted 3 days ago | Updated 5 hours ago

Lead Engineer, Quality Validation

Katalyst Healthcares and Lifesciences

•

Andover, Massachusetts, USA

Full-time

Job Description: The contract Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to laboratory instruments, temperature control units and LFH/BSC units for internal customers. The individual will support and facilitate the review and approval of qualification/validation documentation for all stages of the equipment life cycle qualification process. Responsibilities: Provide quality oversight of Bl
Posted 60+ days ago | Updated 8 hours ago

Software Architect - Embedded

Motion Recruitment Partners, LLC

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Bedford, Massachusetts, USA

Full-time

This is an opportunity to join a global leader in the development of innovative diagnostic technologies. Driven by a commitment to improving patient care, the company focuses on delivering integrated, high-quality diagnostic solutions that enhance clinical outcomes and hospital efficiency. The Embedded Software Architect will serve as a key technical leader across multiple software product lines. This role is responsible for defining and enforcing architectural best practices, guiding the integ
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Posted 42 days ago | Updated 4 hours ago

Program Manager- Medical Device

Judge Group, Inc.

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Marlborough, Massachusetts, USA

Contract

Location: Marlborough, MA Salary: $150,000.00 USD Annually - $165,000.00 USD Annually Description: We are seeking a highly skilled Program Manager to lead the development of large-scale, complex medical device programs, working with both internal and external partners. This role provides technical leadership in design, testing, and system integration while ensuring compliance with industry standards and delivering projects efficiently and within budget. Key Responsibilities Oversee multi-fa
Posted 41 days ago | Updated 5 hours ago

Engagement Manager - Pharma Sales Ops/RWE Experience

Saama Technologies, LLC

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Boston, Massachusetts, USA

Full-time

Description Does solving complex business problems and real world challenges interest you? Do you enjoy seeing the impact your contributions make on a daily basis? Are you passionate about using data analytics to provide game changing solutions to the Global 2000 clients? If you possess a solutions mindset, strong architecting skills, and commitment to be part of a tremendous journey, come join our growing, global Saama team.Saama is seeking a Sr. Business Consultant for our Life Sciences Ana
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Posted 6 days ago

Sr R&D Process Development Engineer

Johnson & Johnson

•

Danvers, Massachusetts, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 2 days ago | Updated 8 hours ago

Data Science Engineer

Takeda pharmaceutical

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Lexington, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by
Posted 60+ days ago | Updated 8 hours ago

Sr. Regulatory affairs Consultant-W2 ONLY

VetForce Solutions

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Remote

Contract

Sr. Regulatory affairs Our client is a rapidly expanding biotech company based in China that recently partnered with a major pharmaceutical company for research collaboration efforts, in hopes of discovering and developing novel oral drug candidates across multiple therapeutic indications (oncology, immunology, etc.) Our client is looking to bring on a Senior Regulatory Affairs Consultant (Senior/Director Level), who will provide strategic regulatory guidance as the client navigates the regulato
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Posted 16 hours ago | Updated 16 hours ago

Sr CAPA Engineer

Fresenius Medical Care

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Remote or Waltham, Massachusetts, USA

Full-time

If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form ADDENDUM: GMS CAPA Office Focus Responsible for development of an appropriate strategy to implement all necessary requirements from FME Quality Management and formerly used NC/CAPA tools into one global electronic NC/CAPA tool. Assists global NC/CAPA process owner with process definition, documentation, implementation, and maintenance.
Posted 60+ days ago | Updated 8 hours ago

Human Factors Engineering Lead - Electrophysiology

Boston Scientific Corporation

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Waltham, Massachusetts, USA

Full-time

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your
Posted 20 hours ago | Updated 8 hours ago

Python Developer - (clinical data)

Radiant System, Inc

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Remote

Contract

Seeking a Python Developer with strong experience in clinical data standards (SDTM/CDISC) and a background in the pharmaceutical industry. Role involves developing automation pipelines and AI/ML models to transform clinical trial data into SDTM-compliant datasets. Must-Haves: 8+ years in pharma/clinical domain 3+ years Python development SDTM, CDISC, ADaM, raw datasets Experience with AI/ML (NLP, classification) Tools: Pinnacle 21, Define.xml Nice-to-Have: Metadata-driven automation Knowledge of
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Posted 14 hours ago

Senior Biostatistician

Georgia IT

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Remote

Contract

Senior Biostatistician Remote Duration: 12+ Months Rate: DOE At least 8years of experienceIn Addition to the above Statistical Programming II experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (CDISC, ICH, FDA/EMA gu
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Posted 11 hours ago