Senior Embedded Tester — Medical Devices (SaMD/IEC 62304)
Digital Technologies, LLC
DIGITAL TECHNOLOGIES LLC is seeking an experienced embedded software testing lead for medical devices in the Boston area. You will drive end-to-end NPI activities, define test strategies, and align automation with IEC 62304 standards. You will oversee communication protocols (BLE, Serial, SPI, UART), utilize sniffers and debugging tools, and ensure compliance with FDA guidelines and SaMD protocols. Collaboration with onsite and offshore teams is required. #J-18808-Ljbffr Digital Technologies, LLC
- Cloud Hybrid Technologies, LLC is seeking an embedded software test engineer to lead end-to-end NPI testing for medical devices. The role emphasizes IEC 62304 compliance, SaMD testing, and collaboration across onsite and offshore teams. Strong communication and leadership...Medical deviceFull time
- Lead end-to-end NPI activities for embedded software testing in medical devices. Oversee Test protocols, test strategy... ...automation testing aligned with IEC 62304 standards. Manage and troubleshoot... ...Ensure compliance with FDA guidelines , SaMD testing protocols, and other...Medical devicePermanent employmentContract workLocal area
$130k - $160k
...Overview We are seeking a Senior Embedded Software Engineer with deep expertise in motion control systems, real‑time embedded software... ...experience in regulated industries, including FDA‑regulated medical devices, with exposure to design controls and verification/...SeniorMedical device- ...together! Sound like you? The Senior Software Engineer provides... ...manage complex electromechanical medical devices. In this role you will... ...firmware utilizing C and C++ on embedded real time operating systems (... ...included ISO 13485, ISO 14971, ISO 62304 as well as FDA QSR 21 CFR...SeniorMedical deviceFull timeLocal area
- Katalyst Healthcares & Life Sciences is seeking an experienced professional for embedded software testing in medical devices. You will lead NPI activities, ensuring compliance with FDA guidelines and managing communication protocols. Ideal candidates should have over 1...Medical device
- ..., Massachusetts is hiring for an experienced role in embedded software testing for medical devices. You will lead NPI activities and ensure compliance with... ..., strong communication skills, and familiarity with IEC 62304 and cybersecurity standards. This position involves...Medical device
$160k - $180k
...processes, software or components of medical diagnostic systems.... ...controls and applicable medical device regulations and standards (e.g., ISO 13485, IEC 62304, 21 CFR Part 820.30) Lead a small... ...pytest‑bdd Hands‑on experience with embedded device test automation Familiarity...SeniorMedical device$130k - $160k
...in robotics, digital solutions, medical devices, diagnostic equipment, defense... ...Boston Engineering seeks a Senior Electrical Engineer with strong experience in embedded systems hardware design, advanced... ...safety or industry standards (e.g., IEC 61508 or related)...SeniorMedical devicePermanent employmentFull timeWork at officeRelocationRelocation package- Axoft in Cambridge, MA is seeking a Senior Embedded Systems Engineer to lead firmware development for implantable brain-machine interfaces. This role involves ownership of low-power embedded software systems, ensuring safety, reliability, and compliance with regulatory...SeniorMedical device
- ...Scientific in Massachusetts is seeking a Senior Design Quality Engineer to lead Design... ...Product Development for cutting-edge medical devices spanning sterile disposables and software... ...and Operations to ensure products meet IEC 62304, FDA guidance and ISO standards across...SeniorMedical device
$160k - $180k
...in Bedford, MA to lead software testing activities focused on medical diagnostic systems. The successful candidate will be responsible... ...conducting peer reviews, and ensuring compliance with medical device regulations. This role requires ten years of product development...SeniorMedical device- CMR Surgical in Cambridge is looking for a Senior Software Engineer to join their Robot Software department. In this role, you will develop embedded software for CMR's medical devices and provide technical leadership within a scrum team. Ideal candidates will have experience...SeniorMedical deviceWork at office
$110.39k - $151.81k
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is... ...and on LinkedIn and X. Senior Technical Writer (Medical/ Software) We are seeking... ...documentation in compliance with IEC 62304, ISO 13485, ISO 14971,... ...as a Medical Device (SaMD) Strong understanding of software...SeniorMedical devicePermanent employmentWork at officeShift workDay shift$140k - $185k
...now hiring for a brand new Senior Firmware Engineer to join the... ...+ years industry experience Embedded C, C++ RTOS - FreeRTOS, VxWorks... ...Understanding with IEC 62304, ISO 14971, ISO 13485 standards... ...Bonus Industry experience for Medical Devices, Nanotechnology, Aerospace,...SeniorMedical deviceImmediate startFlexible hours$93k - $160k
...distributes sterile catheter-, software-, electromechanical-based medical device product families. Provide Quality Engineering support for... ...Guru, MasterControl, ETQ) is a plus • Familiarity with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety) is a...SeniorMedical device$100k - $120k
...sciences, diagnostics, and medical devices. TDB is mandated to become a... ...Contribution Develop and debug embedded firmware for... ...of regulatory standards like IEC 62304 – Medical Device Software Life... ...,000 DOE Additional Details Seniority level: Associate Employment...Medical deviceFull timeTemporary work$110k - $115k
...Job Description Senior International Regulatory... ...ultrasound device, which is now on its... ...In addition to its medical imaging products, Butterfly Embedded™ is the Company's Ultrasound... ...a Medical Device (SaMD) Proven track... ...85, ISO 14971, and IEC 62304 Experience operating...SeniorMedical deviceH1bWork at officeImmediate startFlexible hours2 days per week$140k - $160k
...Summary We are seeking a hands‑on Senior Product Security Engineer to... ...initiatives across the medical device product lifecycle. This role... ...cybersecurity expectations and IEC 81001‑5‑1 standards. Key Responsibilities... ...years focused on product or embedded systems security in regulated...SeniorMedical device- ...are seeking an experienced Embedded System Test Engineer to work... ...compliance with applicable medical device safety and design standards... ...with standards such as IEC 60601, IEC 62304, ISO 13485, and ISO 14971.... ...Relevant experience and skills, Seniority and performance, Market and...Medical devicePermanent employmentFull timeLocal area
- Medical Devices | New Product Development | Design Assurance | Risk Management Are you passionate... ...device organisation is seeking a Senior Design Quality Engineer to play a key role... ...development, ensuring compliance with IEC 62304 and applicable FDA guidance. Support product...SeniorMedical deviceWorldwide
- Senior Design Assurance Quality Engineer Job Description Manage the Design Control and... ...-, software-, electromechanical-based medical device product families. Provide Quality Engineering... ...traceability and compliance to IEC 62304 and FDA guidance documents related to...SeniorMedical device
$170k - $210k
...Software Quality Assurance Senior Manager leads the software quality... ...of software used in medical device systems. This role oversees... ...validation activities across embedded firmware and cloud-based applications... ..., ensuring compliance with IEC 62304 and related regulatory...SeniorMedical deviceWork at officeFlexible hours- Senior Electrical Engineer - Medical Imaging (Bedford, MA) We are seeking a talented Senior... ..., ideally within medical devices or another highly... ...regulatory compliance standards (IEC 60601‑1, EMC, reliability... ...testing). Bonus experience with embedded C, Python‑based automation...SeniorMedical deviceFull time
$157k
Senior Software Architect - Integration (Bedford, MA) We are seeking... ...of the Image Guided Therapy Devices (IGT‑D) team, you will... ...quality, compliant, and innovative medical software products. Your role... ...(FDA, MDR, ISO 13485, IEC 62304) and strong design control practices...SeniorMedical deviceTemporary workWork at officeRelocation package$94k - $150k
...Senior Regulatory Affairs Specialist The Senior Regulatory Affairs... ...of Conformity, and Medical Device Licensesfor various global markets... ...experience required. Experience with SaMD or SiMD submissions is... ...FDA QSR, ISO 13485, ISO 14971, IEC 62304, and other applicable...SeniorMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$170k - $210k
...Software Quality Assurance Senior Manager leads the software quality... ...of software used in medical device systems. This role oversees... ...validation activities across embedded firmware and cloud-based applications... ..., ensuring compliance with IEC 62304 and related regulatory...SeniorMedical deviceHourly payWork at officeFlexible hours$110k - $130k
Lexington Medical, Inc. is seeking an Electrical Engineer to join our R&D team in Bedford, MA. This role involves designing and supporting embedded electrical systems for surgical devices, ensuring reliable hardware-software integration. The ideal candidate holds a B.S....Medical device- ...Electrical Engineer (Senior/Staff/Principal) Nanopath is developing a first... ...integrity, and integration with embedded software and mechanical subsystems... ...developing hardware for medical devices regulated to ISO 13485 and IEC 61010 Experience supporting hardware...SeniorMedical deviceFull timeWork at office
- ...reports in a regulated industry. Experience with data analysis (Minitab, JMP, or MatLAB). Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30‑Design Controls). Excellent project team skills; experience and capability working...SeniorMedical device
- ...trials of drugs, biologics and medical devices. We have a few immediate job... ...-to-end NPI activities for embedded software testing in medical... ...testing aligned with IEC 62304 standards. Manage and troubleshoot... ...with FDA guidelines, SaMD testing protocols, and other...Medical deviceContract workImmediate start
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