Senior Design Quality Engineer

3 weeks ago

Portland, United States Riverpoint Medical Full time

Job Description

Job Description

Riverpoint Medical in Northeast Portland is hiring

a Sr Design Quality Engineer . At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Riverpoint

Sr Design Quality Engineer

will have primary responsibility related to complaint handling, complaint analysis and operations quality support. They will collaborate and improve quality system standards and have overall responsibility to ensure the design, development and design transfer processes are executed appropriately to meet the changing needs of the global regulatory requirements.

Duties and Responsibilities: Develops, coordinates, and conducts technical product/design

validation/verification

studies and evaluations of engineering design concepts. Integral member of new product development team responsible for leading activities required to ensure reliability and quality of the design and manufacturability of the product. Supports ongoing global regulatory compliance including submissions and audits (MDR, ISO 13485, FDA CFRs, etc.). Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes hazards and risk analysis studies of design and processes using ISO 14971, FMEA, and other risk management principles. Compiles and analyzes complaints, performance reports, and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes for improvements in existing or new products. Drives CAPA and Nonconformance investigations and ensures that corrective measures meet acceptable standards. Works cross-functionally to achieve optimal results. Analyzes preliminary plans and develops quality assurance programs to achieve company, customer and governmental agency reliability objectives. Ensure Design Requirements Flow down, predictive modeling, and DRM (Design for Reliability and Manufacturability) are applied. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data. Utilize problem solving tools using Define, Measure, Analyze, Improve, and Control (DMAIC) methodology. Navigate FDA QSR 21 CFR part 820, EU MDR, and ISO 13485 regulations Coordinate planning, implementation and trending of multiple quality management systems including CAPA, SCAR, and non-conformances. Performs supplier audits. Leads component

qualifications/FAIs

to ensure supplier and component requirements perform as intended, as required. Coordinates document change process and documents Ensures device master record, device history record, risk management file are established and meet all production requirements for commercial release.

Education and Qualifications Bachelor Degree in Engineering or similar CAPA planning and implementation Use of Failure Mode Effects Analysis (FMEA) Work experience in an ISO13485 or FDA regulated environment Computer skills, including Word and Excel Demonstrated technical writing skills 3+yrs experience in design assurance or design quality in new product development in an FDA regulated environment is desirable, with an understanding of cGMP, QSR, ISO13485, MDSAP, and MDR

We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays. We also reward our team with bonus pay such as Referral Bonus and Annual Bonus

Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

#J-18808-Ljbffr

  • Senior Design Quality Engineer

    1 week ago

    Portland, United States Riverpoint Medical Full time

    Job DescriptionJob DescriptionRiverpoint Medical in Northeast Portland is hiring a Sr Design Quality Engineer. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies,...

  • Senior Design Quality Engineer

    1 month ago

    Portland, United States Riverpoint Medical Full time

    Job DescriptionJob DescriptionRiverpoint Medical in Northeast Portland is hiring a Sr Design Quality Engineer. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies,...

  • Senior Project Designer

    7 days ago

    Portland, United States Humber Design Group, Inc. Full time

    Humber Design Group, Inc. (HDG), a regional civil engineering firm, has an immediate opening for a full-time Senior Civil Engineering Designer to join our award-winning Portland, Oregon team. The successful candidate will work as a part of our team, serving a key role and contributing to delivering high-quality results to our clients. Project types vary in...

  • Senior Project Designer

    1 week ago

    Portland, Oregon, United States Humber Design Group, Inc. Full time

    Humber Design Group, Inc. (HDG), a regional civil engineering firm, has an immediate opening for a full-time Senior Civil Engineering Designer to join our award-winning Portland, Oregon team. The successful candidate will work as a part of our team, serving a key role and contributing to delivering high-quality results to our clients. Project types vary in...

  • Senior Electrical Design Engineer

    7 days ago

    Portland, United States SEGULA Technologies Full time

    Company Description MUST be authorized to work in the United States for any employer.  Unable to consider CPT or OPT candidates. SEGULA TECHNOLOGIES is assisting our client in hiring a Senior Electrical Design Engineer to join their growing team in in the West / Southwest region of the United States. Our client is an automotive / transportation manufacturer...

  • Civil Engineering Designer

    2 weeks ago

    Portland, United States VLMK Engineering + Design Full time

    Description: VLMK is seeking a Civil Designer with 2 - 4 years of experience who is passionate about engineering and looking for a good place to contribute their professional talents and broaden their experience. As a Civil DESIGNER at VLMK: You will work with a close-knit team where your contribution will be highly valued. You will be a Civil Designer...

  • Senior Electrical Engineer

    3 weeks ago

    Portland, United States IT Motives LLC Full time

    Our client designs, manufactures and integrates hardware and software systems that enable rapid deployment of enterprise-class communications anywhere in the world. They are looking for a Senior Electrical Engineer to join their team in Portland, OR. As a Senior Electrical Engineer, you will be an expert in the electrical design of custom circuit boards. All...

  • Senior Plumbing Engineer or Designer

    1 month ago

    Portland, United States Glumac Full time

    ** Senior Plumbing Engineer or Designer - Portland, OR** **** New Tetra Techs High Performance Buildings Group brings together the expertise of talented engineers, commissioning agents, and energy analysts from around the world. We offer high-end, sustainable building consulting and MEP engineering services for blue-chip clients across every building sector....

  • Senior Design Engineer

    1 week ago

    Portland, United States Southland Industries Full time

    Job DescriptionPosition Summary Are you ready for the next big step in your career where you'll get the opportunity to do things you've never done before? If you're thinking "yes", then we want to hear from you! We are growing and we're looking for a top-notch Senior Design Engineer who has an entrepreneurial spirit and a passion for doing innovative work....

  • Senior Quality Assurance Automation Engineer

    2 weeks ago

    Portland, United States Saxon Global Full time

    Job Title - Senior Test Automation EngineerLocation : Portland , OregonWork Model – 4 days in Ofc Skillset :QA engineer with strong hands on experience on overall STLC processes (Requirement review ,Test Planning , estimation , design , execution ) and can work independently with client stakeholdersStrong hands on experience on automation of websites using...

  • Senior Quality Assurance Automation Engineer

    2 weeks ago

    Portland, United States Saxon Global Full time

    Job Title - Senior Test Automation EngineerLocation : Portland , OregonWork Model – 4 days in Ofc Skillset :QA engineer with strong hands on experience on overall STLC processes (Requirement review ,Test Planning , estimation , design , execution ) and can work independently with client stakeholdersStrong hands on experience on automation of websites using...

  • Senior Mechanical Engineer

    7 days ago

    Portland, United States Curtiss-Wright Full time

    Senior Mechanical EngineerCurtiss-Wright, Defense Electronics, a global leader in defense technologies, is seeking a skilled Senior Mechanical Engineer to join our team in Portland, OR.Location: Portland, ORWe Take Care of Our PeoplePaid Time Off I 401K with Employer Match and Profit Sharing I Health and Wellness Benefits I Learning and Development...

  • Senior Electrical Engineer

    7 days ago

    Portland, United States VanderHouwen Full time

    Senior Electrical Engineer We are looking for a Senior Electrical Engineer to join our team in Portland, OR! As our Senior Electrical Engineer you will be an expert in the electrical design of custom circuit boards. All facets of design will be required. If you are a senior/principal engineer and want to focus on pure electrical design of products, this is...

  • Substation Senior Engineer

    2 weeks ago

    Portland, United States Electrical Consultants, Inc. Full time

    Job DescriptionJob DescriptionElectrical Consultants, Inc. (ECI) is a leading power engineering consultant firm that provides engineering, system planning and studies, technical consultation, project management, surveying, environmental planning, commissioning/testing and construction services to electric utilities, energy developers and industrials...

  • Substation Senior Engineer

    2 weeks ago

    Portland, United States Electrical Consultants Full time

    Job Description Job Description Electrical Consultants, Inc. (ECI) is a leading power engineering consultant firm that provides engineering, system planning and studies, technical consultation, project management, surveying, environmental planning, commissioning/testing and construction services to electric utilities, energy developers and industrials...

  • Senior Mechanical Engineer

    2 weeks ago

    Portland, United States NW Recruiting Partners Full time

    Senior Mechanical Engineer – Healthcare & Higher-TechPortland, OR Are you an experienced Mechanical Engineer with extensive experience in Healthcare, Central Plant, or Higher-Tech? Have you been following mass transit and want to take a deeper dive in hydrogen fueling systems? Are you tired of repetition and want to work on complex projects? If so, this...

  • Substation Senior Engineer

    3 days ago

    Portland, United States Electrical Consultants, Inc. Full time

    Job DescriptionJob DescriptionElectrical Consultants, Inc. (ECI) is a leading power engineering consultant firm that provides engineering, system planning and studies, technical consultation, project management, surveying, environmental planning, commissioning/testing and construction services to electric utilities, energy developers and industrials...

  • Senior Mechanical Engineer

    1 week ago

    Portland, United States Curtiss-Wright Full time

    Senior Mechanical Engineer Curtiss-Wright, Defense Electronics, a global leader in defense technologies, is seeking a skilled Senior Mechanical Engineer to join our team in Portland, OR. Location: Portland, OR We Take Care of Our People Paid Time Off I 401K with Employer Match and Profit Sharing I Health and Wellness Benefits I Learning and Development...

  • Senior Mechanical Engineer

    6 days ago

    Portland, United States Curtiss-Wright Full time

    Senior Mechanical Engineer page is loaded Senior Mechanical Engineer Apply locations US-OR-Portland (PacStar-Parvus) time type Full time posted on Posted 2 Days Ago job requisition id JR5096 Senior Mechanical Engineer Curtiss-Wright, Defense Electronics, a global leader in defense technologies, is seeking a skilled Senior Mechanical Engineer to join our team...

  • Senior Electrical Designer

    1 month ago

    Portland, United States Norwest Engineering, Inc. Full time

    Job DescriptionJob DescriptionDescription: As a Senior Electrical Designer, you will have the opportunity to creatively solve complex problems, coordinate with team members in other engineering disciplines, and develop approaches to widely varied projects which are multi-disciplinary and vary widely in size.· Work with an electrical engineer or...