Senior Design Quality Engineer

2 months ago

New York, United States TransMedics Full time

TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage. The OCS System serves as a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport. Unlike traditional cold-storage methods, the OCS System features ex-vivo, warm perfusion, and provides the means to monitor organ health, so that transplant patients can experience better outcomes. The only multi-organ platform, with the largest body of clinical evidence, the OCS System is designed to increase utilization and transplant volumes so that more transplantable organs can be made available worldwide. The Organ Care System is nothing less than a paradigm shift that can help transform organ preservation and optimization so that more patients can benefit from life-saving transplant procedures.

This position is responsible for various Design Quality Engineering functions in support of product development such as risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support, and statistical analysis.

ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE: Responsible for the overall health of design control process. Responsible for assuring NPI and sustaining projects meet customer expectations, and regulatory requirements. Partner with Development and Engineering departments and ensure that design control requirements are being met in an effective manner in order to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review Provides input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF files for accuracy and completeness and provide guidance on FDA compliance and procedures. Review and approve design control related Change Notices (CNs) within the documentation system as applicable. Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards. Represent the design quality functions for the review and approval of designated design outputs. Act as a subject matter expert on design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV). Support the quality management system as required. Perform other TransMedics task and duties as required.

REQUIREMENTS: BS in Engineering with 8+ years of related experience or equivalent combination of education and experience. Medical device development control experience required. Working knowledge of Software development lifecycle desired. Working knowledge and practical application of 21 CFR Part 820, ISO 13485, ISO 14971. Practical knowledge and experience using Minitab or other statistical analysis tools. Understanding and application of Gage R&R and Measurement System Analysis desired Process validation experience including IQ/OQ/PQ desired. Ability to communicate ideas and information clearly, effectively and concisely. Highly detail oriented with strong organization and prioritization skills.

EDUCATION: BS in Engineering or other technical discipline

  • Senior Civil Design Engineer

    3 weeks ago

    New York, United States Hirani Group Full time

    Job Title Senior Civil Design Engineer Location Hirani New York City Office - New York City, 10001 US (Primary) Category Construction Job Type Full-time Job Description Job Title: Senior Civil Design EngineerWe are currently seeking a highly skilled and experienced Senior Civil Design Engineer to join our clients at New York and contribute to their ongoing...

  • Project Engineer

    1 month ago

    New York, United States Engineer Rec Full time

    Our client are seeking Project Engineers for multiple projects along the East Coast, USA. Are you a Project Engineer currently looking for a new challenge and experienced in supporting offshore wind projects? If so please read on. The Project Engineer has the skills and experience to take a leading role related to land and underground installation of high...

  • Project Engineer

    3 weeks ago

    New York, United States Engineer Rec Full time

    Our client are seeking Project Engineers for multiple projects along the East Coast, USA. Are you a Project Engineer currently looking for a new challenge and experienced in supporting offshore wind projects? If so please read on. The Project Engineer has the skills and experience to take a leading role related to land and underground installation of high...

  • Transportation Senior Engineer

    1 month ago

    New York, United States Rinker Design Associates, LLC Full time

    RDA has excellent advancement opportunities for mid to senior-level civil engineering professionals. This position will provide leadership opportunities for the development of highway designs, intersection improvements, interchange improvements, and pedestrian facility improvements, including the development of technical reports, project schedules, budgets,...

  • Senior Designer/Project Manager

    2 weeks ago

    New York, United States Julie Hillman Design Full time

    Summary:Julie Hillman Design, a high end residential Interior Design firm, seeks a Senior Interior Designer/Project Manager to join the team. The ideal candidate will have a background in residential Interior Design with strong project management skills and experience working with high quality vendors, suppliers and service providers. You must be able to...

  • Highway/Roadway/Civil Senior Design Engineer

    1 month ago

    New York, United States HNTB Full time

    The time is right to join HNTB Corporation! HNTB is currently seeking a Highway/ Roadway/ Civil--Senior Design Engineer to join our expanding Design Build Group. At HNTB, you can create a meaningful career while building communities that matter to al Design Engineer, Engineer, Design, Senior, Project Manager, Technical, Technology, Construction

  • Senior Hardware Design Engineer

    3 days ago

    New York, United States Voyant Photonics Full time

    Voyant Photonics is bringing the next generation of sensors to market- reducing cost and size by more than 90 percent and bringing semiconductor scaling to 3D sensing. Senior Hardware Design Engineer This position puts you at the heart of our team. Working closely with each component development team, you’ll be leveraging your engineering skills,...

  • Design Engineer

    1 month ago

    New York, United States United Employment Group, Inc. Full time

    Position Objectives: Perform structural analysis and design and 3D CAD modeling of precast, post-tensioned, concrete tanks. Assist senior engineers to oversee the preparation of Erection and Production drawings. Position Responsibilities: Perform structural analysis and design of precast, post-tensioned concrete tanks in compliance with appropriate design...

  • Senior Quality Assurance Engineer

    4 weeks ago

    New York, United States Bridgewater Consulting Group, Inc. Full time

    We are seeking a highly skilled and experienced Senior QA Engineer for a DERMS integration project. As distributed energy resources (DERs) continue to gain traction with both energy providers and their customers, monitoring and managing flexibility has become a mission-critical activity. Distributed energy resource management systems (DERMS) are platforms...

  • Senior Quality Assurance Engineer

    1 month ago

    New York, United States Bridgewater Consulting Group, Inc. Full time

    We are seeking a highly skilled and experienced Senior QA Engineer for a DERMS integration project. As distributed energy resources (DERs) continue to gain traction with both energy providers and their customers, monitoring and managing flexibility has become a mission-critical activity. Distributed energy resource management systems (DERMS) are platforms...

  • Senior Quality Assurance Engineer

    3 weeks ago

    New York, United States Bridgewater Consulting Group, Inc. Full time

    We are seeking a highly skilled and experienced Senior QA Engineer for a DERMS integration project. As distributed energy resources (DERs) continue to gain traction with both energy providers and their customers, monitoring and managing flexibility has become a mission-critical activity. Distributed energy resource management systems (DERMS) are platforms...

  • Senior Quality Assurance Engineer

    3 weeks ago

    New York, United States Bridgewater Consulting Group, Inc. Full time

    We are seeking a highly skilled and experienced Senior QA Engineer for a DERMS integration project. As distributed energy resources (DERs) continue to gain traction with both energy providers and their customers, monitoring and managing flexibility has become a mission-critical activity. Distributed energy resource management systems (DERMS) are platforms...

  • Senior Electrical Engineer | Design Project Management

    2 days ago

    New York, United States CareerPoint Staffing Full time

    Title: Senior Electrical Engineer | Design Project Management ` Our client: For over forty years, our client continues to provide high-quality engineering services, offering a full range of MEP services such as HVAC, Electrical, Plumbing, Fire Protection, LEED and Sustainable Services and Commissioning. As a mid-size firm, our client can offer the depth of a...

  • Senior Hardware Design Engineer

    1 week ago

    New York, United States Voyant Photonics Full time

    Job DescriptionJob DescriptionVoyant Photonics is bringing the next generation of sensors to market- reducing cost and size by more than 90 percent and bringing semiconductor scaling to 3D sensing. Senior Hardware Design EngineerThis position puts you at the heart of our team.  Working closely with each component development team, you’ll be leveraging...

  • Senior Quality Assurance Engineer

    5 days ago

    New York, United States Harbor.ai Full time

    About Harbor.ai:Harbor.ai is an early-stage InsurTech startup aiming to revolutionize the enterprise insurance market. Our technology simplifies the process for insurance brokers to identify optimal coverage for their clients continuously, and this is just the beginning. Our mission is to revolutionize underwriting for better, faster, and smarter processes....

  • Senior Quality Assurance Engineer

    6 days ago

    New York, United States Harbor.ai Full time

    About Harbor.ai:Harbor.ai is an early-stage InsurTech startup aiming to revolutionize the enterprise insurance market. Our technology simplifies the process for insurance brokers to identify optimal coverage for their clients continuously, and this is just the beginning. Our mission is to revolutionize underwriting for better, faster, and smarter processes....

  • Senior Quality Assurance Engineer

    2 days ago

    New York, United States Harbor.ai Full time

    About Harbor.ai: Harbor.ai is an early-stage InsurTech startup aiming to revolutionize the enterprise insurance market. Our technology simplifies the process for insurance brokers to identify optimal coverage for their clients continuously, and this is just the beginning. Our mission is to revolutionize underwriting for better, faster, and smarter processes....

  • Senior Quality Engineer

    7 hours ago

    New Bedford, Massachusetts, United States Lexington Medical Full time

    Lexington Medical is a medical device manufacturer in the greater Boston area that produces minimally invasive surgical stapling solutions. Our unique customer-centric approach to engineering has allowed us to be agile and responsive to the stapling market and has yielded 3x revenue growth in the last two years. Our business structure enables us to produce a...

  • Senior UX Designer

    3 weeks ago

    New York, United States Motion Recruitment Full time

    Grow your career as a UX Designer with an innovative global bank in New York, NY. Contract role with strong possibility of extension. Will require working a hybrid schedule 3 days onsite per week. Join one of the world's most renowned global banks and trusted brand with over 200 years of continuously evolving financial services worldwide. Will be...

  • Senior design engineer

    1 month ago

    New York, United States Graphite Inc Full time

    Graphite builds consumer-quality tools for modern software engineering teams so they can ship faster and create amazing products. Our product Graphite is modern code review for fast-moving teams - we help engineers write and review smaller pull requests, stay unblocked, and ship faster. Anyone can start using Graphite individually without needing their...