Medical Device Design Quality Engineer - Risk & V&V
Katalyst CRO
Katalyst CRO in Minnesota seeks a Regulatory/Design Controls Engineer to ensure compliance across the medical device lifecycle, with emphasis on ultrasound/imaging domains. You will drive design controls, risk analysis, V&V efforts, and regulatory alignment to ISO 13485 and 14971 while collaborating with cross-functional teams. Ideal candidates have strong systems thinking, experience with DFMEA, and proficiency in requirement management tools, such as DOORS or Jama, to support risk-based #J-18808-Ljbffr Katalyst CRO
- ...for ensuring compliance to design controls, risk management, and verification... ...the product lifecycle for medical devices, with a strong preference for... ...product lifecycle Systems engineering Experience In DFMEA / risk... ...tools (DOORS, Jama, etc.) V&V execution and review Regulatory...RiskMedical device
- ...ambitions. About the role:This Principal Software Design Quality Engineer position will support active implantable medical devices. This position serves as a leader in design... ..., software verification and validation (V&V), risk management, cybersecurity, and regulatory...RiskMedical deviceHourly payWork at officeLocal areaRemote workRelocation packageShift work3 days per week
- ...have a high-impact opportunity for a Senior Design Quality Engineer to lead design assurance efforts for a critical medical device in the Electrophysiology space. This role requires... ...for system integration, design decisions, risk management, and software development &...RiskMedical deviceHourly payRelocation packageShift work3 days per week
$95.9k - $129.47k
...True to Life, by advancing medical technologies and... ...Job DescriptionThe Product Quality Engineer is responsible for the design, development and management... ...and procedures and medical device regulations. The Product... ...problems. Lead Process/Design Risk Analysis. Provide...RiskMedical deviceFull timeLocal areaWorldwideFlexible hours$150k - $175k
...process. Principal Design Assurance Engineer Full Time... ...disease states and medical specialties. We... ...requirements through device concept and launch... ...user needs and risk controls. Define... ...development processes, the Quality Management System... ..., and software V&V. Experience...RiskMedical deviceFull timeTemporary workVisa sponsorship$102.1k
...About the role: This Principal Software Design Quality Engineer position will support active implantable medical devices. This position serves as a leader in design... ...controls, software verification and validation (V&V), risk management, cybersecurity, and regulatory...RiskMedical deviceHourly payWork at officeLocal areaRemote workRelocation packageShift work3 days per week$110k - $127.5k
...innovative, mission-driven Quality team as a Sr. Design Assurance Engineer at Endologix!WHO WE ARE:... ...California-based global medical device company dedicated to... ...Propels Us: We take smart risks and are unafraid in our... ...verification and validation (V&V), and risk management...RiskMedical deviceFor contractorsLocal areaWork from homeFlexible hours- ...Description Job Description Job Summary Quality Engineer II to ensure that products,... ...Management System (QMS). Identify quality risks and assess compliance with internal... ...and problem-solving Experience in medical-device manufacturing or a regulated...RiskMedical deviceFor contractors
- ...We are looking for a Supplier Quality Engineer at HCLTech the role entails Evaluate and onboard... ...Quality or related roles within the Medical Device industry. Strong knowledge of... ...quality processes. Experience with PPAP, risk management, process validation, and...RiskMedical device
- ...are seeking a qualified QA Validation Engineer to support quality assurance, process validation, and... ...validation activities within a regulated medical device manufacturing environment. The ideal... ...requirements. Identify quality risks, assess compliance gaps, and...RiskMedical device
$105.87k - $158.8k
...Interventional Urology Senior Design Assurance Engineer is responsible for... ...and document risks (Hazard Analysis, DFMEA... ...Design Assurance specific quality system deliverables... ...: Comprehensive medical, dental, and vision insurance... ...´ s leading medical device companies. We are...RiskMedical deviceContract workImmediate startFlexible hours$53 per hour
...Description Job Title: Design Assurance Engineer Job Description... ...Assurance Engineer (Quality Engineer), is responsible... ...Design Assurance on risk management updates... ...validations. Review Device History Records (DHRs... ...5 years of relevant medical-device experience, or...RiskMedical deviceFull timeContract workTemporary workWork at office$79.26k - $107k
...to Life, by advancing medical technologies and elevating... ...Description Provide Quality Engineering support to ensure... ...preferably in the medical device industry related to... ...Mapping, Histograms, FMEA, Risk Assessment, Cause &... ...by producing products designed with the purpose of delivering...RiskMedical deviceFull timeLocal areaWorldwide- ...multiple disease states and medical specialties. We offer... ...Matters) The Sr. Supplier Quality Engineer will lead the product... ...This role will work with Design Assurance on risk management updates and the... ...process validations Reviews Device History Records (DHR) and...RiskMedical deviceFull timeTemporary work
$100.9k - $151.3k
...Quality Engineering ManagerCretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our capabilities include injection molding, laser processing... ...and implementing robust, risk-based inspection and...RiskMedical deviceHourly payContract workTemporary workLocal areaShift work$70k - $90k
...Description ABOUT INSPIRE MEDICAL SYSTEMS Inspire... ...of its kind medical device designed to make a difference... ...process improvements, quality system requirements and... ...Bachelor's degree in an engineering discipline such as... ...~ Experience with risk management standard ISO...RiskMedical deviceWork experience placementLocal areaFlexible hours$110k - $140k
I'm working with a rapidly growing medical device company developing groundbreaking therapeutic... ...'re looking to add a Senior Supplier Quality Engineer to their team.This is a highly visible... ...and manufacturing processes * Support risk management and continuous improvement...RiskMedical device- ...Title: Quality Engineer III Location: Saint Paul, MN Duration: 12Months 100% Onsite Pay: $45... ...2 Qualifications 3–5 years experience Medical Device Quality experience (Ops or Manufacturing... ...and Inspection Plans Data Integrity Risk Assessments (DIRA) Validation Master Plans...RiskMedical device
- ...DescriptionJob DescriptionDesign Assurance engineer to represent the Quality function on a product... ...engineer would be a key contributor to risk management and design verification planning and... ...Assurance in Life Sciences Industry IVD medical device environment a plus· Experience...RiskMedical device
- ....comMust HaveDesign Assurance/Design Quality/Reliability General quality experience in med device Nice To HaveLean/six sigma experience... ...studies and evaluations of engineering design concepts and design of... ...reliability. - Completes risk analysis studies of new design...Risk
$80k - $120k
...developing innovative medical technologies that... ...LifeThe Supplier Quality function supports... ...cross-functional engineering and manufacturing... ...regulated medical device environment.This position... ....Experience with risk management,... ...compensation plans designed to support you at...RiskMedical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours$100k - $140k
Software Test Engineer / Senior Software Test Engineer... ...and innovative medical device organization is seeking... ...teams to ensure product quality, reliability, and compliance... ...This role focuses on designing and executing test... ...reliability.Participate in risk-based quality...RiskMedical device- ...Description Job Description Job Title: Quality Engineer IV Job ID: 19574-1 Location:... ...field. • 7+ years of experience in medical device quality, post-market surveillance, complaint... ...to apply technical judgment and risk-based thinking to solve complex problems...RiskMedical device
- ...Best Workplaces for Engineers in 2026,... ...will participate in medical device software verification... ...a strong focus on quality and expertise in requirements... ...the planning, design and execution of... ...and validation (V&V) strategies, test... ...cases and security risk controls.Experience...RiskMedical deviceHourly payWork at officeRelocationRelocation packageShift work3 days per week
- ...: Spencer Gregory HaleSenior Quality Systems EngineerAbout the role:The Senior Quality Systems Engineer provides technical leadership... ...trends to identify systemic risks and drive data-based improvements... ...3+ years of experience in a medical device manufacturing, quality or...RiskMedical deviceHourly payWork at officeShift work3 days per week
- ...Job Summary The Supplier Quality Engineer is responsible for ensuring... ...procedures within the medical device industry. This role involves... ...qualification and onboarding, risk assessment, supplier audits,... ...Drawings, Capability Studies, Design Failure Mode and Effects Analysis...RiskMedical device
- ...DescriptionFiagon NA, LLC designs, develops,... ...and markets advanced medical devices for use in the healthcare... .../ Process Development Engineer to support our increasing... ...performance, regulatory, and quality requirements.Design... ...in design reviews, risk assessments, and product...RiskMedical deviceWork at office
$135k - $157.5k
...innovative, mission-driven Quality team as a Staff Supplier Quality Engineer- Contract Manufacturing... ...California-based global medical device company dedicated to... ...through precision in product design, advanced manufacturing,... ...Us: We take smart risks and are unafraid in our...RiskMedical deviceContract workFor contractorsLocal areaWork from homeFlexible hours- ...summary: We are seeking a Senior Quality Engineer Quality Systems to support and drive quality... ...system activities within a regulated medical device manufacturing environment. The ideal... ...investigations, root cause analysis, risk management, statistical analysis,...RiskMedical device
$20 - $26 per hour
...padding: 0px; } R&D Quality Engineer Co-OpTemporary About HeraeusMaking... ...hearts beat with medical innovations? Or... ...life-changing medical devices to market through partnerships... ...in areas like design, testing, manufacturing... ...specifications, performing risk assessments, and...RiskMedical deviceFull timeWorldwide
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