ISO 13485 jobs in Boston, MA

Sr. Supplier Quality Engineer (ONLY W-2 role)

Bedford, Massachusetts

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13d ago

Position Title: Sr. Supplier Quality Engineer (PHIAJP00004186) Location: Bedford MA Duration: 12 months Positions Requested: 2 Hours per Week: 40 (8 hrs/day) Notes from the manager: Major focus in experienced Process Validation, Verification across plastic, metal and electronics along with problem solving for candidates to support +700 parts for part qualification for Spectrawave products. The product contains Catheter and Console (System) products. Manufacture engineering, Product Quality, and/

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Contract

50 - 55

Litigation Associate (Complex Business)

Boston, Massachusetts

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Today

Medical Device Leader! Principal Quality Engineer Opportunity! This Jobot Consulting Job is hosted by: David DeCristofaro Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $65 - $85 per hour A bit about us: We are a leading medical device company that operates privately and is committed to enhancing the care and quality of life of patients with kidney disease. Our goal is to create cutting-edge solutions that enable patients and their healthcare

Full-time

Compensation information provided in the description

Drug Delivery Test & Evaluation Engineer

Boston, Massachusetts

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Today

Job Title: Senior R&D Engineer, Drug Delivery Systems (Test & Evaluation) Role Overview We are seeking a hands-on Drug Delivery Test & Evaluation Engineer to join a multidisciplinary R&D team dedicated to pioneering innovative delivery systems. In this role, you will apply core engineering and scientific principles to evaluate the performance of formulation and device prototypes. You will be responsible for the end-to-end testing lifecycle-from designing custom experimental setups to executing

Full-time

USD 158,100.00 - 158,100.00 per year

Validation Engineer

Boston, Massachusetts

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Today

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

Product Design Quality Engineer

Cambridge, Massachusetts

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Today

Job Description: The Product Design Quality Engineer is responsible for supporting quality throughout the product development lifecycle by ensuring compliance with regulatory requirements, quality standards, and design control processes. This role partners with cross-functional teams to integrate quality into product development, risk management, validation, and manufacturing transfer activities. Responsibilities: Support Design Control activities throughout the product development lifecycle in

Full-time

Senior Software Quality Assurance Engineer

Andover, Massachusetts

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Today

Job Description As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and compliance across the product development lifecycle for Class II/ medical devices, including software-driven and active implantable products. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commerc

Full-time

Senior Systems Test Engineer - Electrophysiology

Waltham, Massachusetts

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Today

Additional Location(s): US-MN-Arden Hills 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 -

Full-time

USD 89,200.00 - 169,500.00 per year

Imaging Service Engineer I (Boston, MA)

Boston, Massachusetts

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Today

Position Overview An Imaging Service Engineer I is responsible for performing scheduled service work on systems within a service area, and some unscheduled work in the service area with the assistance of technical support, as directed by the Area Service Manager. Company Overview At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagno

Full-time

USD 32.69 - 38.46 per hour

Senior Mechanical Engineer

Marlborough, Massachusetts

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Today

Senior Opto-Mechanical EngineerII-Medical Devices Duties Lead development of complex medical devices and subsystems through all development phases from design input through verification and validation to manufacturing transfer stages and in coordination with overall system requirements; Assist in developing IP portfolio for these instruments and provide original technical solutions to improve performance, functionality, reliability costs requirements; Develop product specification in coordinati

Full-time

Principal Engineer, Mechanical 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 157,080.00 - 227,460.00 per year

Design Assurance Engineer / Class II Medical Devices

Marlborough, Massachusetts

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Today

A leading global technology company is looking for a Design Assurance Engineer to join their team in Marlborough, MA. This is a full-time opportunity supporting the development and sustaining of advanced Class II electro-mechanical medical devices, with a focus on design controls, risk management, verification and validation, regulatory compliance, and technical documentation. This is a great opportunity for a Design Assurance Engineer with 3-5 years of Class II electro-mechanical medical device

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Full-time

$74000 - $99000

Design Assurance Engineer / Medical Devices

Marlborough, Massachusetts

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Today

A leading global technology company is looking for a Design Assurance Engineer to join its team in Marlborough, MA. This is a great opportunity for an engineer with 3-5 years of medical device experience who wants to take on meaningful work across the full product development lifecycle. You'll help develop and improve Class II electro-mechanical medical devices while working closely with Design Engineering, Quality, Regulatory, and external testing teams. You'll have the opportunity to work on p

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Full-time

$74000 - $105000

Associate Technical Project Manager

Acton, Massachusetts

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Today

Job#: 3045356 Job Description: Apex Systems is a world-class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients' digital visions. Apex has an opportunity for a Associate Technical Project Manager. Interested candidates can send an updated resume to Dan Hornby, Account Manager, at . Here are the details: Position: Associate Technical Project Manager Location: Acton, MA Hybrid to Acton, MA. Onsite expectations: Up to 1

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Full-time

$48 - $52 per hour

Software Architect

Bedford, Massachusetts

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Today

Our client is a global leader in medical diagnostics, developing innovative technologies that support hospitals, laboratories, and healthcare providers around the world. With decades of industry leadership and a strong commitment to research and development, the company continues to invest in next-generation diagnostic platforms that improve patient care through advanced software and instrumentation. This is an outstanding opportunity for an experienced Software Architect to join a highly collab

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Full-time

$175000 - $225000

Engineer, Quality Engineering

Wilmington, Massachusetts

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Today

Full-time

USD 75,200.00 - 103,400.00 per year

Product Development Compliance Engineer

Needham, Massachusetts

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Today

About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people's lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains.

Full-time

USD 72,700.00 - 111,400.00 per year

Senior Engineer, Quality Engineering

Wilmington, Massachusetts

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Today

Full-time

USD 95,600.00 - 131,450.00 per year

Medical Devices Design Assurance Engineer

Marlborough, Massachusetts

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Today

A leading global technology company is looking for a Design Assurance Engineer to join their team in Marlborough, MA. This is a full-time opportunity supporting the development and sustaining of advanced medical device products, with a focus on design controls, risk management, verification and validation, regulatory compliance, and electro-mechanical medical device technologies. You'll work closely with Design Engineering, Regulatory teams, and external testing organizations to help bring safe,

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Full-time

$74000 - $99000

Manufacturing Technician I

Lawrence, Massachusetts

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2d ago

Client LocationCountry: United StatesState/Province: MassachusettsCity: LawrenceAddress: 360 Merrimack Street, Lawrence*LawrencePOSTAL CODE: 01843Duties: Execute consumables manufacturing processes according to established Standard Operating Procedures (SOPs) Maintain strict adherence to quality standards and efficiency metrics Operate in cleanroom environments following contamination control protocols Handle consumable materials with precision under guidance of Group Leaders or trai

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Contract, Third Party

$25 - $25

Verification & Validation Test Engineer

Marlborough, Massachusetts

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Today

IPG Photonics is revolutionizing the laser industry as the pioneering developer and leading producer of fiber lasers and amplifiers. Headquartered in Marlborough, MA, IPG has over 4,800 employees in more than 30 locations around the world. We aspire to work together with our employees and customers to apply light in ways that improve life. Our mission is to develop innovative laser solutions to make the world a better place. To accomplish this mission, we are committed to attracting and retainin

Full-time

ISO 13485 jobs in Boston, MA, USA