FDA Jobs in Massachusetts

41 - 60 of 107 Jobs

Clinical Data managerJob Title - Clinical Data manager

Intone Networks Inc.Company Name - Intone Networks Inc.

•

Remote

Third Party, Contract

Need stronger with working on Data Acquisition, DTAs and vendor relations. Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.Provide support in setting up infrastructure for external data to flow into T

Clinical SAS programmerJob Title - Clinical SAS programmer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Boston, Massachusetts, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures, and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases. Perf

Principal Validation EngineerJob Title - Principal Validation Engineer

Johnson & JohnsonCompany Name - 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

Job Title: Product Manager Healthcare RemoteJob Title - Job Title: Product Manager Healthcare Remote

Think Big Solutions, IncCompany Name - Think Big Solutions, Inc

•

Remote

Contract

Job Title: Product Manager Healthcare Location: [City, State or Remote] Job Type: [Full-Time / Part-Time / Contract] Job Summary: We are seeking an experienced and strategic Product Manager with a background in healthcare to lead the development and execution of products that improve patient outcomes, provider workflows, or payer efficiency. The ideal candidate will have a strong understanding of healthcare systems, regulations (e.g., HIPAA, HL7, FHIR), and the complexities of healthcare deliver

Software Verification EngineerJob Title - Software Verification Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Newton, Massachusetts, USA

Full-time

Job Description: We are seeking a meticulous and detail-oriented Medical Device Software Verification Tester to join our team. The successful candidate will be responsible for verifying software used in our medical devices and ensuring compliance with regulatory standards and internal quality requirements. This role involves designing, implementing, and executing test plans and procedures to identify and document software defects. Responsibilities: Test Planning and Design. Develop comprehensi

Sales headJob Title - Sales head

Showman StaffingCompany Name - Showman Staffing

•

Remote

Full-time

Job Title: Sales Head Experience: 6+yrs Location: Remote-Travel required(100% travel) Job: Permanent Full Time Requirement Role Overview We are seeking a passionate and driven Sales professional to accelerate our growth in the Healthcare and MedTech space one of the most rapidly evolving sectors today. You will work with a high performing team targeting innovative healthcare providers, MedTech firms, and digital health disruptors to bring cutting-edge technology solutions to life. You will repr

DTS Lead - Intelligent Clinical Supply ManagementJob Title - DTS Lead - Intelligent Clinical Supply Management

Quantum Integrators Group LLCCompany Name - Quantum Integrators Group LLC

•

Remote or King of Prussia, Pennsylvania, USA

Third Party, Contract

Role Name: DTS Lead - Intelligent Clinical Supply Management (ICSM) Location: King of Prussia, PA. REMOTE 6+ Months contract Job Description The DTS Lead ICSM is responsible for leading the design, implementation, and optimization of SAP's Intelligent Clinical Supply Management (ICSM) solution. This role supports clinical trial operations by ensuring efficient planning, forecasting, packaging, labeling, and distribution of clinical trial materials across global sites, while maintaining regulato

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

Michael Page InternationalCompany Name - 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

Automation EngineerJob Title - Automation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

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

Computer System Validation Analyst - R Studio & Clinical SystemsJob Title - Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana

Senior Mechanical EngineerJob Title - Senior Mechanical Engineer

Motion Recruitment Partners, LLCCompany Name - Motion Recruitment Partners, LLC

•

Boston, Massachusetts, USA

Full-time

Our client, a leading medical device company, is seeking a Senior Mechanical Engineer to join their R&D team. This role involves contributing to the design, development, and support of diagnostic systems and electromechanical components in a regulated environment. The ideal candidate will have a strong background in mechanical design, experience with complex assemblies, and a track record of bringing products from concept through development and into manufacturing. This is a hands-on engineering

Senior Commissioning, Qualification & Validation (CQV) EngineerJob Title - Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

•

Remote or Athens, Georgia, USA

Full-time

Site Compliance Quality HeadJob Title - Site Compliance Quality Head

Software Guidance & AssistanceCompany Name - 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

Lead Engineer - MES OpcenterJob Title - Lead Engineer - MES Opcenter

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new

Engineer III, ValidationJob Title - Engineer III, Validation

Thermo Fisher ScientificCompany Name - 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

Lead Mechanical EngineerJob Title - Lead Mechanical Engineer

Motion Recruitment Partners, LLCCompany Name - 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

Lead Engineer, Quality ValidationJob Title - Lead Engineer, Quality Validation

Katalyst Healthcares and LifesciencesCompany Name - 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

Senior Appian DeveloperJob Title - Senior Appian Developer

General DynamicsCompany Name - General Dynamics

•

Remote

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on

Associate Director, Human Factors & Usability EngineeringJob Title - Associate Director, Human Factors & Usability Engineering

Sanofi U.S.Company Name - Sanofi U.S.

•

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

Sr. R&D EngineerJob Title - Sr. R&D Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

•

Remote or New Brighton, Minnesota, USA

Full-time