Medical Device Software Risk & Quality Lead
Socket.dev
Axoft is seeking a Design, Process, and Software Quality Risk Specialist to own organizational risk management across product design, development processes, and software. The role prioritizes software risk but supports risk management across the organization as the device and quality system mature. Ideal candidates have hands-on experience with FMEA or structured risk assessment, some grounding in quality systems, and sufficient software literacy to engage engineers. #J-18808-Ljbffr Socket.dev
$50k
...to develop and ensure quality execution of services,... ...and Mission - to be the leading provider of automation... ...in pharmaceutical or medical device validation ~5+ years... ...-E2500 ~ ISO 14971 – risk management for medical... ...and associated software systems Holistic understanding...QualitySoftwareRiskMedical deviceTemporary workFor contractorsWork experience placementWork at officeWeekend work$175k - $225k
...growing, Boston-based medical technology company... ...care - leading to better patient... ...outcomes, improved quality of care, and reduced... ...experience in the medical device industry and 2-5+... ...guiding software development lifecycle... ...including audits, CAPA, risk management and...QualitySoftwareRiskMedical deviceWork at officeLocal area- ...Design Quality EngineerResponsible for ensuring compliance to design controls, risk management, and verification/validation activities... ...the product lifecycle for medical devices, with a strong preference for... ...electrical safety)IEC 62304 (software lifecycle)IEC 62366 (...QualitySoftwareRiskMedical device
- ...documentation for combination drug-device and biologic products,... ..., EU MDR, and internal quality standards throughout... ...activities. Perform risk management activities,... ...in a regulated medical device or combination product... ...JAMA and Windchill software ~ Ability to work...QualitySoftwareRiskMedical device
$155k - $185k
...and help scale the execution of our Software as a Medical Device programs. This role will partner closely... ..., Clinical, Regulatory, and Quality to plan and deliver against program milestonesWork... ...key deliverables and identifying risks earlySupport development in...QualitySoftwareRiskMedical deviceFull timeWork at officeRelocation$120k - $160k
...global market access activities for Software as a Medical Device (SaMD), wearable technologies, and digital... ...and communicate regulatory impacts, risks, timelines, and submission... ...stakeholders.Provide occasional support for Quality Management System activities, audits,...QualitySoftwareRiskMedical deviceFull timeWork at officeRelocation$130k - $170k
...growing, Boston-based medical technology company... ...care - leading to better patient... ...outcomes, improved quality of care, and reduced... ...cardiovascular imaging software used in a highly regulated... ...as a Medical Device (SaMD) environment... ...including vendor risk assessments and...QualitySoftwareRiskMedical deviceWork at office$88.6k - $246.6k
The Solution Implementation Lead is the end‑to‑end execution owner... ...of new connected medical device and digital health solutions.... ...including milestones, dependencies, risks, constraints, and mitigation... ...issues. Solution‑Level Readiness, Quality & ComplianceEnsure solution‑...QualityRiskMedical deviceFull timePart timeImmediate startRemote workWorldwide$170k - $230k
...that work: building and leading the engineering and science... ...across regulatory, quality, clinical science, product, software, and firmware to deliver... ...operate inside a regulated medical device development environment... ...regulatory rigorOwn the risk posture for your function...QualitySoftwareRiskMedical deviceFull timeWork at officeRelocation$150k - $210k
...addressing any issues related to data and data quality. Contribute to ongoing research efforts and explore... ...developing or supporting regulated or high-risk ML systems (e.g., digital health, software as a medical devices), including familiarity with validation, documentation...QualitySoftwareRiskMedical deviceFull timeWork experience placementWork at officeRelocation- ...and validate hardware, and drive risk management for EEG and cardiopulmonary device systems in a regulated environment... ...with hardware, firmware, software, and product teams, and support transition... ...contract manufacturers, ensuring quality and regulatory compliance. #J-18...QualitySoftwareRiskMedical deviceContract work
- ...Team Lead To assist the Project Manager in ensuring successful monitoring... ...associated with a particular software lifecycle phase by guiding the assigned... ...manner Assist Project Manager in Risk Management and participate in quality reviews and implement quality norms...QualitySoftwareRisk
$95k - $145k
...Consultant, Regulatory, Risk, and Compliance. This... ...be responsible for… Lead end-to-end validation... ...attention to detail and quality of work productAbility... ...including pharma, biotech, medical device, or clinicalExperience... ...validating cloud or software as a service platforms...QualitySoftwareRiskMedical deviceRemote workVisa sponsorship- ...Trenchless Geotechnical Team Lead will report to the Trenchless... ...utilizing OpenGround and/or gINT software, which will also include... ...drawings.Perform data management and quality control of geological data.Aid... ...estimating, scheduling and risk management for all geological...QualitySoftwareRiskFor contractorsLocal areaRemote work
$136.4k - $253.2k
...Data Science is recognized as a leading hub for top industry talent,... ...the delivery of high-quality, regulatory-compliant analytical... ...proactively addressing potential risks to support internal audits... ...promoting best practices in software development, analytics tooling...QualitySoftwareRiskFull timeLocal area$103.6k - $176.4k
...Validation (V&V) strategy for Software as a Medical Device (SaMD) and SaaS platforms.... ...regulatory compliance, quality metrics, traceability, and... ...standards.Key Responsibilities: Lead and define software V&V... ...matrices linking requirements, risks, and verification and...QualitySoftwareRiskMedical deviceHourly payFull timeTemporary workMonday to FridayFlexible hours$210k - $230k
...Clinical Operations, you will lead the clinical operations... ...with a particular focus on Software as a Medical Device (SaMD). You will own operational... ...studies, ensuring high-quality, efficient, and compliant execution... ...progress, operational risks, resource needs, vendor...QualitySoftwareRiskMedical deviceFull timeWork at officeRemote workRelocation- ...authoring/development of quality solutions that meet... ...how pharmaceutical and medical device companies use... ...solutions and articulate risks and benefits* Provide... ...experience with declarative software configuration* Proven... ...consulting company that leads with outcomes to bring...QualitySoftwareRiskMedical deviceLocal areaShift work
- ...Manufacturing Engineer Medical Device The Senior... ...emphasizes efficiency, quality, regulatory compliance... ...validation, including risk assessments and critical... ...validations. Lead or contribute to pFMEA... ...Office and statistical software like Minitab or JMP....QualitySoftwareRiskMedical deviceContract workWork at office
$142.3k - $195.7k
...founding engineer. As Lead, Offensive Security (AI... ...company, and you ship the software that proves it.It's a... ...and operating production-quality software and tooling,... ...Applications, and the NIST AI Risk Management Framework.... ..., Humana provides medical, dental and vision benefits...QualitySoftwareRiskFull timeTemporary workFor contractorsWork at officeRemote workWork from homeHome office$114k - $182k
...on complex distributed software solutions. You’ll work... ...team to deliver world leading, cutting-edge Patient... ...Clinical Engineering, and Risk Management teams to... ....Drive SW FMEA for medical device software and solutions... ...everywhere has access to the quality healthcare that we all...QualitySoftwareRiskMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$118.3k - $207.4k
...accounting, finance, audit, risk, compliance and... ...Wolters Kluwer's market leading information-enabled tools and software solutions to manage their... ...needs into scalable, high-quality product solutions that meet... ...including but not limited to: Medical, Dental, & Vision Plans,...QualitySoftwareRiskFull timeWork at office- ...health. We are the leading at-home sleep test... ...sleep testing devices integrate multi-channel... ...enables high-quality clinical diagnostics... ...hardware, firmware, software engineers and... ...system verification, risk management, system... ...Experience developing medical devices or other...QualitySoftwareRiskMedical deviceContract workWork experience placementWork at officeRemote work
$142.3k - $195.7k
...our caring communityThe Lead Solutions & AI... ...technology including hardware, software, databases, and peripherals... ...delivery readiness and quality assurance.Demonstrated... ...checkpoints and risk reviews; ensure designs... ...benefits, Humana provides medical, dental and vision benefits...QualitySoftwareRiskFull timeTemporary workFor contractorsWork at officeRemote workWork from homeHome office$103k - $145k
Job TitleSenior Design Quality EngineerJob DescriptionIn this role... ...hardware quality and safety risk management throughout the product... ...a regulated environment with Medical Device experience. 5+ years of... ...(IEC 14971), Medical Device Software Life Cycle Processes (IEC 623...QualitySoftwareRiskMedical deviceFull timeWork at officeImmediate startRemote workWork visaRelocation package3 days per week$238k - $374k
...Regulatory Affairs CMC Devices and Drug-Device... ...strategies for medical devices and drug-device... ...product, quality, clinical, development... ...you will contribute:Leads and develops a... ...usability/human factors, risk management, and... ...biocompatibility, software and cybersecurity...QualitySoftwareRiskMedical deviceMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide- ...edge products to life-saving medical devices. Our 3D printing technology powers... ...development to perform risk assessments, manage continuous... ...experimental setup to hardware and software implementation in Python.... ...field failure analysis or quality engineering roles is a plus....QualitySoftwareRiskMedical deviceFull timeWork at officeWorldwideFlexible hours
$127k - $202k
...Job DescriptionYour role:Leading structured sustainment programs... ...schedules, dependencies, risks, and issue tracking,... ...on scope, timelines, quality, and compliance.Owning the... ...management for a portfolio of medical devices, including hardware, Software as a Medical Device (SaMD...QualitySoftwareRiskMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$190k
...Enterprise Application and Risk functions. We balance... ...strategies into leading-edge tech platforms, at... ...decisions and shape high-quality technical solutions.Comfortable... ...years of experience in software engineering, data... ...We pay the full cost of medical, dental, and vision coverage...QualitySoftwareRiskWork at officeLocal area- ...lifecycle management of Class II medical devices. Provide regulatory guidance... ...with Research & Development, Quality Assurance, Clinical,... ...regulatory input to design controls, risk management, change control,... ...MDR, Canada). Experience with software-enabled, electrical, or...QualitySoftwareRiskMedical device
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Medical Device Software Risk & Quality Lead. Be the first to apply!
- entry level medical device sales Cambridge, MA
- regulatory affairs manager medical devices Cambridge, MA
- medical device Cambridge, MA
- bank software Cambridge, MA
- software asset management analyst Cambridge, MA
- ultimate software Cambridge, MA
- embedded software Cambridge, MA
- software Cambridge, MA
- software engineer - cloud services Cambridge, MA
- internship software Cambridge, MA



