FDA jobs in Watertown, MA

Hybrid in Watertown, Massachusetts

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2d ago

Title: VP of ITLocation: Watertown, MA (Hybrid: 3-4 days/week onsite)Duration: Direct HirePosition Summary: We need a technology strategy that keeps pace with growing complexity across regulatory, scientific, and business needs. As our first VP, IT, you'll build and own that strategy, getting systems and infrastructure phase-appropriate before scale becomes a bottleneck. This is a highly cross-functional, hands-on leadership role, with real ownership to build the function from the ground up. Ke

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Full-time

Depends on Experience

Senior Design Quality Engineer

Andover, Massachusetts

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Today

Role name: Senior Design Quality Engineer Work Location: Andover, MA Start date: Immediate availability. Interview Mode: Phone/Video Type: Contract (C2C/W2) Senior Design Quality Engineer Location: Andover, MA OR Remote Qualifications: Bachelor's degree in Software Engineering, Computer Engineering, Systems Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline Advanced degree (Master s) in Engineering, Quality, or Regulatory Affairs preferred Re

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

GRC Analyst

Remote

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3d ago

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

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Contract

$60 - $70

Validation Engineer

Boston, Massachusetts

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14d ago

Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred. Roles & Responsibilit

Full-time

Embedded Verification and Validation (V&V) Engineer

Waltham, Massachusetts

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Today

Experience: 10+ years of commercial software test engineering experience, with a proven track record in a medical device or scientific instrument environment.Deep Embedded Expertise: Extensive, hands-on experience testing deeply embedded systems where software directly controls physical hardware components.Regulatory Mastery: Proven commercial experience testing and shipping medical devices under ISO 13485, along with familiarity with current FDA cybersecurity requirements.Testing Methodologies:

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Full-time

$130,000 - $140,000

CSV Validation Engineer

Boston, Massachusetts

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14d ago

Job Summary We are seeking a Medical Device Quality / CSV Validation Engineer to support quality system compliance, CAPA remediation, spreadsheet validation, and computer system/software validation activities within a regulated medical device environment. The ideal candidate will have strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk Roles & Responsibilities Review spreadsheet inventories and assess validation requirements based on applicable procedures, risk, and quality standards. Perfo

Full-time

Clinical Engineer II

Boston, Massachusetts

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Today

POSITION SUMMARY: Under general direction performs a variety of very skilled repair and maintenance activities on sophisticated anesthesia, patient monitoring and other patient related equipment located in critical care and surgery. Performs in-depth troubleshooting and diagnostics on sophisticated technology. Assists in the initiation and completion of clinical evaluations. Assists in the compilation of a sensible capital acquisition plan for the Medical Center's operating rooms. Assists in th

Full-time

USD 42.87 - 55.46 per hour

Senior Principal GMP Compliance Auditor

Cambridge, Massachusetts

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Today

Location: Cambridge, MA Salary: $95.00 USD Hourly - $135.00 USD Hourly Description: Title: Principal GMP Compliance Auditor Type: 10+ Month Contract Location: Remote with travel domestic and international Seeking a Senior Principal GMP Compliance Auditor to lead independent GMP audits across pharmaceutical manufacturing sites, laboratories, suppliers, CMOs, and quality systems. This role serves as a subject matter expert in global regulatory compliance, inspection readiness, and quality sys

Contract

Compensation information provided in the description

Sr CAPA Engineer

Remote or Waltham, Massachusetts

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Today

PURPOSE AND SCOPE: Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area. PRINCIPAL DUTIES AND RESPONSIBILITIES: Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.Ensure product quality is achieved at the receiving manufacturing site level during product transfer projectsPartner with CE vertical quality, R&D team

Full-time

Senior Engineer, Quality Engineering

Wilmington, Massachusetts

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Today

About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's inno

Full-time

USD 95,600.00 - 131,450.00 per year

CSV Engineer (Analyst II)

Cambridge, Massachusetts

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14d ago

About the job: The Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems, including both on premises and Cloud/Server based applications, are validated and controlled in compliance with industry standards and regulations. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, conducting risk assessment, and providing valida

Full-time

Sr. Process & Operations Engineer

Boston, Massachusetts

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Today

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making bette

Full-time

USD 130,000.00 - 150,000.00 per year

Sr. Product Development Engineer - Boston, MA

Boston, Massachusetts

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Today

Full-time

Product Quality Engineer 2

Marlborough, Massachusetts

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Today

Job Description Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on-market medical devices. In this role, you'll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you'll drive process improvements, assess risks, and de

Full-time

USD 78,000.00 - 122,100.00 per year

Computer Systems Validation Engineer

Boston, Massachusetts

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Today

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our Foundational Principles: - W

Full-time

USD 75,000.00 - 106,000.00 per year

Software QA Engineer II

Newton, Massachusetts

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Today

Location: Newton, MA Salary: $50.00 USD Hourly - $60.00 USD Hourly Description: Our client is currently seeking a Software QA Engineer II Job Title: Software QA Engineer II Location: Newton, MA 02458 Duration: 1+ Years Position Overview We are seeking an ambitious Software QA Engineer II to join our Endovascular Robotics business within Advanced Therapies. This team develops robotic-assisted vascular intervention technology combining endovascular robotics, image guidance, and dedicated medi

Contract

USD 50.00 - 60.00 per hour

Sr. Software QA Engineer

Newton, Massachusetts

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Today

Location: Newton, MA Salary: $58.00 USD Hourly - $60.00 USD Hourly Description: Job Title: Sr. Software Qa Engineer Location: Newton, MA Duration:- 12+ Months Position Overview We are currently looking for an ambitious Sr. Software QA Engineer (Contractor) to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance and dedicated devices wil

Contract

USD 58.00 - 60.00 per hour

Mechanical Engineer

Foxborough, Massachusetts

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Today

Dear Candidate, My name is Manisha Singh and I am a recruiter at Stellent IT LLC. I am reaching out to you on an exciting job opportunity with one of our clients. Should you be interested, please send me a copy of your resume in word format along with your LinkedIn URL. We have a Mechanical Engineer role that is full time if you are interested. Need American born s no job shoppers. Candidates need to have a LinkedIn Profile as well. Vertical is Medical Device Mechanical Engineer - Medical Dev

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Full-time

AI/ML & Computer Vision Lead

Marlborough, Massachusetts

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Today

Job Description Job Summary AI/ML & Computer Vision Lead is responsible for the identification, evaluation, and integration of artificial intelligence and computer vision capabilities across Hologic's GYN Surgical capital platforms, including ultrasound-guided fibroid ablation, hysteroscopy consoles, and associated imaging and visualization systems. This role serves as the primary technical and strategic interface between internal R&D teams, external AI and imaging technology partners, and cro

Full-time

USD 128,200.00 - 200,500.00 per year

Human Factors Engineer 4

Marlborough, Massachusetts

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Today

Job Description Job Summary: Lead Human Factors Engineer possessing deep expertise in human factors engineering, usability engineering, and user-centered design to support and lead the development of safe, effective, and intuitive medical devices from concept through commercialization. Essential Duties and Responsibilities: The incumbent may be asked to perform other function-related activities in addition to the below mentioned as responsibilities as reasonably required by business needs. T

Full-time

USD 128,200.00 - 200,500.00 per year

FDA jobs in Watertown, MA, USA