Senior Design Assurance Engineer - Med Device Quality DHF
$100k - $130kCypress HCM
Cypress HCM is looking for a Senior Design Assurance Engineer in Maple Grove, Minnesota. This role involves ensuring quality input and deliverables for new product development in medical devices. Candidates should have over 5 years of experience in medical device development and possess strong knowledge of quality systems and risk management practices. The position offers a competitive salary of $100,000 - $130,000 plus a 15% bonus. #J-18808-Ljbffr Cypress HCM
- ...Job Role: Senior Design Assurance Engineer - Medical Device (Onsite - Arbor Lakes, MN) Contract Overview: From development to commercialization, we... ...with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and...QualitySeniorFull timeContract work
$91.35k - $146.16k
Job TitleSenior Design Assurance EngineerJob DescriptionThe Senior Design Assurance Engineer will play a critical role... ...Image Guided Therapy Devices (IGTD).Your role: Ensures... ...planning as well as quality system compliance.... ...Design History Files (DHF).You have the proven...QualitySeniorFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...your ambitions. About the role:This Senior Design Assurance Engineer will work on the Axonics Integration... ...integration of products and Design Control quality system processes, the product and... ...product development or related medical device / regulated industry experience Self-...QualitySeniorHourly payWork experience placementWork at officeLocal areaRemote workRelocation packageShift work3 days per week
- HistoSonics, Inc. in Plymouth, MN seeks a Sr. Design Assurance Engineer to lead design quality assurance for medical device software and hardware projects. The role emphasizes IEC 62304 software life cycle activities, risk management, and design controls within product...QualitySeniorFull time
- ...client of ours is seeking an experienced Design Assurance Engineer to support product development and... ...for ensuring that product designs meet quality, regulatory, and customer requirements... ...and compliance. Candidates with medical device experience are highly preferred;...QualitySeniorWork at office
$100k - $130k
A medical device manufacturing client is looking to hire a Senior Design Assurance Engineer in Maple Grove. This person will be responsible for design of quality input and deliverables for new product development... ...Design History Files (DHF) Advise project teams and lead...QualityContract work- ...exciting opportunity to join our team as a Senior Design Assurance Engineer. You will be part of a team working... ...file documentation and overall quality system compliance. Ensures... ...management for novel and existing medical devices, including risk management plans and...QualitySeniorWork experience placement
$110k - $127.5k
...Join our innovative, mission-driven Quality team as a Sr. Design Assurance Engineer at Endologix!WHO WE ARE:Endologix... ...a California-based global medical device company dedicated to improving... ...Engineering and works day to day with senior Quality and R&D team members on...QualitySeniorFor contractorsLocal areaWork from homeFlexible hours- ...your ambitions. About the role:The Senior Design Quality Engineer provides support with high visibility... ...recently launched and established medical devices against risk assessmentsActively... ...5+ years experience in design assurance, new product development, or related...QualitySeniorHourly payRelocation packageShift work3 days per week
- ...We have an exciting opportunity for Senior System Design Quality Engineer supporting a cross-functional team... ...clinical knowledge to influence how devices they are working on are tested and... ...Minimum of 5 years experience in design assurance, quality, or related medical device...QualitySeniorHourly payRelocation packageShift work3 days per week
$110k - $140k
...alternative application process. Sr. Design Assurance Engineer Full Time Plymouth, MN, US 2 days ago... ..., MN Position Summary: The Sr. Design Quality Assurance Engineer will support design... ...has a particular emphasis on medical device software developed under IEC 62304, while...QualitySeniorFull timeTemporary work- ...responsible for operational quality input and deliverables... ...lifecycle. Quality Assurance Engineers will also support... ...accurate and compliant Design History File. All engineering... ...Design History Files (DHF). o Advise project... ...experience in medical device development, or 3+...QualitySeniorTemporary work
- ...innovative robotic technologies designed to enhance the treatment... ...Summary The Design Assurance Engineer directly supports medical device product development from... ...management activities, and DHF compliance to ensure delivery of the highest quality product. Essential...QualityWork at office
$61.3k - $122.7k
Design Assurance Engineer II - Plymouth, MN Responsibilities Lead and implement... ...development projects including quality improvement initiatives.... ...validation activities. Ensure DHF content integrity,... ..., ISO 14971. Prior medical device experience, especially electrophysiology...QualityFor contractors- Boston Scientific is seeking a Senior Design Quality Engineer to support high-visibility quality initiatives and sustainment activities for ARDEN HILLS and CARLSBAD sites. This role partners with R&D, manufacturing, supplier teams, and cross-site groups to ensure design...QualitySenior
- Boston Scientific is hiring a Senior Design Quality Engineer for Bolt Integration at the Arbor Lakes Campus in Maple Grove, MN. The role requires collaboration across R&D, manufacturing, supplier and regulatory functions to protect design intent and ensure safety and compliance...QualitySeniorRelocation package3 days per week
- Abbott in Plymouth, MN seeks a Design Assurance Engineer II to lead development projects and ensure design... ...verification/validation for medical devices. The role requires coordinating cross‑... ...re‑certifications while maintaining DHF integrity and compliance with FDA regulations...
- ...3 skills sets required? General quality experience in med device; Design Assurance/Design Quality; self-driven, independent... ...product. Collaborates with engineering and manufacturing functions to ensure... ...and Influence: Communicates with senior internal and external customers...QualitySenior
- HistoSonics, Inc. in Plymouth, MN, is seeking a Sr. Product Assurance Engineer to lead quality activities for commercial production, including... ...material handling, and risk management coordination with Design Assurance. The role collaborates with Manufacturing and Supply...QualitySenior
- ...- whatever your ambitions. About the role The Principal Design Quality Assurance Engineer will bring their leadership to sustaining projects for our... ...System for Medical Electrical Equipment (MEE) and single use device (SUD) as part of a core group of Design Quality Assurance...QualityHourly payRelocationShift work3 days per week
$110k - $140k
...application process. Sr. Product Assurance Engineer Full Time Plymouth, MN, US... .... This role will work with Design Assurance on risk management... ...validations Reviews Device History Records (DHR) and completes... ..., modifies, and maintains quality system procedures, work...QualitySeniorFull timeTemporary work- ...ENGINEER II - Medical Device Product Development & Manufacturing... ...supports the design, development, validation... ...with the Quality Management System... ...technical problems to senior engineering staff... ...History File (DHF) and Device Master... ...responsibility of Quality Assurance and Regulatory...QualityFull timeWork at office
- ...Holdings is seeking a Product Development Engineer III to drive design and development from concept through... ...work closely with manufacturing, quality, and product teams to ensure robust product... ...project leadership within medical device environments. #J-18808-Ljbffr...QualitySenior
$75.3k - $150.7k
...Senior Regulatory Quality Specialist Abbott is a global healthcare leader that... ...in diagnostics, medical devices, nutritionals and branded generic... ...device technologies are designed to help people live their... ...Regulatory systems projects to assure business needs are met and...QualitySeniorWork experience placementShift work$100k - $130k
....footer div p { padding: 0px; } Senior Engineer - Quality Design AssurancePermanent About HeraeusMaking... ...lifesaving and life-changing medical devices to market through partnerships with... ...responsibility of the Quality Design Assurance Senior Engineer position is to lead...QualitySeniorFull timeWorldwide$103k - $145k
Job TitleSenior Design Quality EngineerJob DescriptionIn this role you Will be part of a team... ...throughout the product life cycle.A Quality Engineer provides independent oversight of the... ...a regulated environment with Medical Device experience. 5+ years of experience...QualitySeniorFull timeWork at officeImmediate startRemote workWork visaRelocation package3 days per week- ...programs and regulatory submissions. You will collaborate with Quality, Engineering, and Commercial teams across the product lifecycle. Ideal... ...candidates have 12+ years in regulatory affairs within medical devices, strong communication skills, and experience #J-18808-...QualitySenior
$76k - $141.1k
...expertise to projects (i.e. Heat Transfer, Hydraulic Network Design, Sheet Metal Design, Weldment Design, etc.).Perform analysis... ...processes, etc.Collaborate with PMO, operations, manufacturing engineers, quality engineers to simplify designs and improve manufacturability...QualitySeniorMinimum wageFull timeTemporary workWork experience placementWork at officeLocal areaFlexible hours- Job description: Sr SW Quality Assurance Engineer, medical devices, remoteThis role both actively participates in the development of product and non-product... ...for the risk management file, compliance with design control regulations, development of design requirements...QualitySeniorRemote work
- ...Senior Software Business Analyst Our Fortune 500 Medical Device client has an exciting opportunity for a Senior... ...product managers, engineers, QA, regulatory, and clinical... ...processes (e.g., design control, traceability,... ..., compliance, and quality. Other Details: Schedule...QualitySeniorContract work
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