Staff Quality Engineer, SaMD & Medical Device Software
Johnson & Johnson MedTech
Johnson & Johnson is seeking a Staff Quality Engineer, Product Software Development, to lead quality efforts on medical device software projects, including SaMD. You will drive risk assessments, test strategies, and design controls while guiding cross-functional teams. Required candidates will have a background in regulated industries, SDLC for medical device software, and experience mentoring engineers. Travel and audits may be involved. #J-18808-Ljbffr Johnson & Johnson MedTech
- ...activities across the product lifecycle for medical devices, with a strong preference for... ...controls & product lifecycle Systems engineering Experience In DFMEA / risk analysis... ...60601 (electrical safety) IEC 62304 (software lifecycle) IEC 62366 (usability) Ultrasound...Software
$109k - $174.8k
...Development Job Sub Function R&D Software/Systems Engineering Job Category Scientific/... ...Job Description The Staff Quality Engineer, Product... ...responsible for the development of medical device software systems. The... ...as a Medical Device (SaMD) products. Provide leadership...SoftwareLocal areaImmediate start$170k - $220k
WHOOP is seeking a Staff Regulatory Affairs Associate to develop regulatory strategies for Software as a Medical Device (SaMD) and other digital health solutions. This role requires 8+ years of experience in Regulatory Affairs, particularly in the medical device industry...Software$170k - $220k
WHOOP is looking for a Staff Regulatory Affairs Associate to shape the regulatory strategy for digital health and AI-enabled... ...This role involves developing regulatory approaches for Software as a Medical Device (SaMD) and serving as a primary advisor to cross-functional...Software- ...Verification & Validation (V&V) strategy for Software as a Medical Device (SaMD) and SaaS platforms. This role is... ...regulatory compliance and ensuring quality standards aligned with FDA... ...proven leadership skills to mentor engineering teams. The position offers a comprehensive...Software
$155k - $185k
..., Inc. is seeking a Senior Program Manager, SaMD, based in Boston, MA. The role focuses on executing Software as a Medical Device programs, collaborating with cross-functional... ..., ideally familiar with FDA pathways and Quality Management Systems. The position offers a competitive...Software$155k - $185k
WHOOP is seeking a Senior Program Manager, SaMD, located in Boston, MA. This role involves driving execution of Software as a Medical Device programs, collaborating with various teams to ensure regulatory compliance and successful product delivery. Candidates should have...Software- ...Senior Manufacturing Engineer Medical Device About the job Senior Manufacturing Engineer Medical Device... .... The role emphasizes efficiency, quality, regulatory compliance, and cost-effectiveness... ...in Microsoft Office and statistical software like Minitab or JMP. Preferred Skills:...SoftwareContract workWork at office
$102k - $163k
Philips is seeking a Software Design Assurance Quality Engineer in Cambridge, MA. This role focuses on ensuring top-level design quality assurance for cloud-based medical software used in medical monitoring, ensuring accuracy and regulatory compliance. The ideal candidate...SoftwareWork at office- A software services company is looking for a Test Engineer who will develop and execute functional test plans, alongside... ...to maintain software quality. This full-time role requires a... ...field, with experience in HL7/FHIR medical device interfacing and a detail-oriented...SoftwareHourly payFull time
$165k - $185k
...partner develops innovative medical products used across... ...are expanding their engineering team and are looking... ...teams to deliver high‑quality, compliant products.... ...circuits for medical device applications Perform... ...firmware, mechanical, software, systems, and test engineers...SoftwareRemote work1 day per week- IndSoft Inc is looking for a Software Test Engineer to join their team in Cambridge, MA. The ideal candidate will work closely with software... ...thorough testing and validation for software deployments in medical applications. You will lead testing efforts, support continuous...Software
$155k - $185k
...looking for a Senior Program Manager, SaMD to join our growing team and help scale the execution of our Software as a Medical Device programs. This role will partner... ...with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and deliver against...SoftwareFull timeWork at officeRelocation- Mechanical Design Engineer : Medical Device : Electromechanical : Robotics : Mechanisms... ...to well tenured senior staff. Critical needs... ...Collaborate closely with electrical, software, systems, and manufacturing... ...medical devices under a quality system (ISO 13485 or FDA QSR...SoftwareFull time
- ...Job Title: Senior Quality Assurance Analyst Duration: 5+ months contract... ...hospital stays, and many other important medical services. EOHHS (EHS) is developing a strategic... ...test cases and scenarios to ensure software compliance. will also work closely...SoftwareContract workRemote work
- 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...Software
- ...application developments. Liaise with end users, development staff, system administrators, management, and staff from other... ...and other integration technologies ~10+ years of experience in software development. ~ Strong technical expertise in Java/J2EE, Oracle...SoftwareWork experience placementShift work
$21 - $36 per hour
...support of PCs, printers, peripherals, and mobile devices. This individual also supports all standard operating systems and software applications. The position requires an... .... Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) as a condition...SoftwareWork experience placementLocal areaRemote work- ...Title: QA Automation Engineer Location: Quincy MA Start: ASAP - 3 weeks after acceptance Duration: through June 30th 2027... ...Qualifications Required: 3 - 5 years of professional experience in software quality assurance or testing (or equivalent training/education)....SoftwareImmediate startRemote workShift work
- Philips is hiring a Regulatory Affairs leader in Cambridge, Massachusetts, focusing on strategic regulatory leadership for software-enabled medical devices. The role involves developing regulatory strategies, guiding new product introductions, and ensuring compliance with...Software
$240k - $265k
...execution. Partner with product managers, engineering teams, data specialists, and client... ...design standards, decision frameworks, and quality assurance mechanisms across engagements.... ...enterprise architecture, technology consulting, software engineering, or related technology...SoftwareMinimum wageFlexible hours- A leading consulting firm is seeking a skilled NPI Quality Engineer to support medical device development. You will work with various teams to ensure compliance with industry standards such as ISO 13485 and FDA regulations. Ideal candidates will have a Bachelor's degree...Contract work
- A leading medical technology company is searching for a Program Manager (Sustaining... ...sustainment programs of medical devices, ensuring compliance and quality while managing cross-functional... ...have over 7 years of experience in software medical device product development...SoftwareRelocation package
- ...expertas. Gestiona varios proyectos simultáneamente cumpliendo plazos ajustados. Mantente al día con las tendencias del sector y el software. Operar y mantener el equipo de impresión, garantizando un rendimiento y seguridad óptimos. Ofrece un servicio al cliente y...Software
- ...CI/CD Agile Automation Quality Engineering Software Testing As a Senior Quality Engineer at Fandom in Poznan, you will be a key player in ensuring... ...options Company swag packages Cafeteria Benefit Program (medical care, gym, shopping/wellness bonus) VTO (Voluntary Time Off...SoftwareFlexible hours
- Fidelity Investments is seeking a Senior Software Engineer in Test to join Fidelity TalentSource in Boston, MA. You will design automated testing solutions and drive quality across the development lifecycle, collaborating with engineers, product owners and architects....Software
- ...ProArch (pro•ark) has been an emerging leader in Advisory and Software Development solutions. ProArch is your strategic partner providing... ...team of Architects, Project Managers, Business Analysts and Engineers; each with a keen knowledge of the Cloud and its potential....Software
- A medical technology company is seeking a Staff Power Electronics Engineer in Boston to drive high-stakes engineering challenges in power electronics and analog circuit design. You will oversee rigorous design and implementation processes, from schematic capture to lab...
$40 - $42 per hour
...equivalent combination of education and experience Great customer service and end user empathy Technical proficiency with a variety of software, hardware and applications Must be able to multi-task and prioritize well Experience using ticketing system to track incidents...SoftwareContract workInternshipLocal areaRemote work- ...platforms using connectors/APIs. Experience working with agile methodology. Responsibilities Participate in all aspects of the software development lifecycle including requirement gathering, estimating, technical design. Demonstrate troubleshooting skills in customization...Software
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