fdma Jobs in boston, ma

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Staff Device Engineer

Takeda pharmaceutical

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 Primary Role: The Staff Device Engineer will lead technical efforts for combination products and drug delivery device projects with

Senior Program Leader

Sanofi EU

Cambridge, Massachusetts, USA

Full-time

Job Title: Senior Program Leader Location: Morristown, NJ or Cambridge, MA 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. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the indus

Automation Engineer

Merck KgaA

Stoneham, Massachusetts, USA

Full-time

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious mind

Engineer III - Combination Product Development

Takeda pharmaceutical

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 OBJECTIVE: The Engineer will support Takeda's combination product development efforts for use in clinical studies and for commercia

Journeyman Telecommunications Deployment Engineer

GovCIO

Boston, Massachusetts, USA

Full-time

Overview GovCIO is currently hiring for a Journeyman Unified Communications Deployment Engineer to provide telecommunications support to their local area, and travel around the US for unified communications deployment activities. This position is primarily located in Boston, MA and is an onsite position. Responsibilities Performs a variety of electronic and technical assignments on data, telecom, and audiovisual communications equipment and systems. Completes endpoint troubleshooting using ap

Engineer I, Medical Device Design Control Documentation Specialist

Amgen Inc

Remote or Cambridge, Massachusetts, USA

Full-time

Career Category Operations Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each

Head of Engineering

Sanofi U.S.

Framingham, Massachusetts, USA

Full-time

Job Title: Head of Engineering Location: Framingham, MA 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. Sanofi's Mass BioCampus (MBC) Engineering organization is responsible for providing Engineering support to organizations

Systems Engineer

Mindlance

Remote

Contract

Job Description: Must-Haves: 1. Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment. 2. Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards. 3. Jama Connect Proficiency: Hands-on experience using Jama Connect tool to manage requirements management and traceability

Senior Software Test Engineer - Electrophysiology

Boston Scientific Corporation

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

Senior Software Test Engineer - Electrophysiology

Boston Scientific Corporation

Cambridge, 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

Laboratory Technician 1

Net2Source Inc.

Walpole, Massachusetts, USA

Contract

Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA and we are hiring "Job Title" for one of our clients. We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/1000 to Start-ups across various verticals like Technology, Financial Services, Healthcare, Life Sciences, Oil & Gas, Energy, Retail, Telecom, Utilit

Product Security Engineer

Apex Systems

Danvers, Massachusetts, USA

Full-time

Job#: 2061518 Job Description: Position: Product Security Engineer Location: Remote (supporting EST hours) Primary Duties And Responsibilities Partner with engineering teams (cloud, console, pump, etc.) to drive successful adherence to the product security program.Create, update, and mature product security processes.Deliver documentation for pre-market development activities including security plans, architecture and data flow diagrams, threat models, requirements, SBOM, and risk documentation.

Sr. Software Quality Engineer

Fresenius Medical Care

Remote or Lawrence, Massachusetts, USA

Full-time

Position Location Details - Upon agreement between you and your supervisor, you are entitled to a flexible arrangement where you will be able to split your time between working from the office and working remotely. PURPOSE AND SCOPE Act as a Quality Business Partner for Software as a Medical Device and Non-medical software device engineering teams to ensure compliant products, engineering teams are supported with a value-added mindset, and Post Market Surveillance activities are performed, and

SAP Plant Maintenance Consultant

IT Resonance Inc.

Remote

Contract, Third Party

Hi, Here is an Remote Contract Job opportunity for below position. Role: SAP Plant Maintenance (PM) Consultant Location: IL, Remote + (Occasional Travel) Contract Duration: 12+ Months Experience: 10 + Year skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards, Nirmal Kumar Phone:- Email:-

SS - Business Quality Assurance role

Apex 2000

Remote or Indianapolis, Indiana, USA

Contract, Third Party

Hi Please sendin resume and ph# Business Quality Assurance (BQA) Location = Indianapolis, IN / remote Total Yrs. of Experience - 10-12 YEARS Relevant Yrs. of experience - 7 to 12 years Mandatory skills Strong knowledge in GMP, cGMP, regulatory standards (21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, ICH Q7) Experience in facing FDA audits associated with pharma manufacturing units Hands-on experience with manufacturing processes, CAPAs, deviations etc. Lead Auditor or any other compliance c

Regulatory affairs - CMC Manager

Sureminds Solutions

Remote

Contract

Title : Regulatory affairs - CMC Manager Location: Remote This will be 100% remote in the US only PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product su

LabVantage LIMS Specialist Remote Location

Sierra Business Solution LLC

Remote

Third Party, Contract

LIMS Support Engineer Location: Boston, MA Skill: Labvantage experience is must Role Description: ? 3-5 years of experience providing IT support for LIMS systems in a pharmaceutical, biotech, or laboratory setting. ? Experience with LabVantage LIMS is strongly preferred experience with LabWare LIMS also considered. ? Strong understanding of laboratory processes, sample management, and analytical workflows. ? Experience with LIMS system configuration, master data updates, and user management. ? F

Senior QT C++ Software Engineer

Medtronic

Remote or Newton, Massachusetts, USA

Full-time

We anticipate the application window for this opening will close on - 12 May 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic is seeking a highly skilled and experienced Senior Software Engineer to join our Affera Mapping and Ablation System Software Team. This role is

Computer Systems Validation Engineer

Corporate Solutions General, Inc.

Remote or San Francisco, California, USA

Full-time, Part-time, Third Party, Contract

Computer System Validation Engineer (CSV) SFO, CA Onsite Contract Client : Cellares Minimum 10+ Years experience required .5 year in Pharma domain Job Roles and Responsibilities: * Develop, execute, and document test protocols for system qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). * Ensure that software is properly validated and compliant with internal and external standards, such as FDA 21 CFR Part 11, GxP, an

Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

Zachary Piper Solutions, LLC

Remote or Atlanta, Georgia, USA

Full-time

Piper Companies is Senior Manager for Regulatory Affairs Labeling Strategy to join the team a global biopharmaceutical company focused in neurology and immunology. In this role, you will lead labeling strategies, ensuring compliance with regulatory requirements while supporting product development and commercialization. This preferred candidate will be located in the Atlanta, GA or Raleigh, NC regions, however candidates outside of these regions will be considered as well. Responsibilities of