Current jobs related to Principal Quality Engineer - Boston, Massachusetts - Medtronic

  • Principal Software Engineer

    4 weeks ago

    Boston, Massachusetts, United States Motion Recruitment Full time

    Principal Software EngineerBoston, Massachusetts-based company seeks a skilled Principal Software Engineer to join their mission-driven team.This is a full-time role with the option for remote work, offering a dynamic, collaborative environment that celebrates innovation and rapid growth.As a Principal Software Engineer, you'll drive the design and...

  • Principal Network Engineer

    2 weeks ago

    Boston, Massachusetts, United States Insight Global Full time

    Insight Global is seeking a highly skilled Principal Network Engineer to join a financial services organization in Boston, MA. This financial services organization provides wholesale funding for housing and community finance for partnering financial institutions across New England.The engineer will be a vital member of the network engineering team, within...

  • Data Engineering Principal

    3 weeks ago

    Boston, Massachusetts, United States CarGurus Full time

    We're seeking a seasoned Data Engineering Principal to join our team at CarGurus. As a key member of our Data Engineering team, you'll be responsible for transforming raw data into clean, reliable, and organized data models that drive informed decision-making across the organization.With a strong background in data modeling and a passion for innovation,...

  • Principal Site Reliability Engineer

    4 weeks ago

    Boston, Massachusetts, United States Global InfoTek Full time

    Job Title: Principal Site Reliability EngineerWe are seeking a highly skilled Principal Site Reliability Engineer to join our team at Global InfoTek, Inc. The ideal candidate will have a strong background in cloud infrastructure, DevOps, and reliability engineering.Key Responsibilities:Design and implement scalable cloud infrastructure solutionsDevelop and...

  • Principal Mechanical Engineer

    4 weeks ago

    Boston, Massachusetts, United States Motion Recruitment Full time

    Job Title: Principal Mechanical Engineer - MechatronicsOur client, a pioneering automotive start-up, is seeking a highly skilled Principal Mechanical Engineer with a focus on mechatronics to lead their engineering team in creating advanced robotic systems.Key Responsibilities:Lead the design and development of mechatronic systems, including robotic arms,...

  • Principal Civil Engineer

    2 weeks ago

    Boston, Massachusetts, United States Toole Design Group Full time

    About the RoleWe are seeking a highly experienced and talented Principal Civil Engineer to join our team at Toole Design Group in Boston, MA. As a key member of our engineering team, you will lead and mentor an interdisciplinary team to deliver multimodal transportation infrastructure projects in a wide range of contexts.Key ResponsibilitiesLead and mentor...

  • Principal Systems Engineer

    4 weeks ago

    Boston, Massachusetts, United States Warwick consulting Full time

    Job Title: Principal Systems EngineerWarwick Consulting is seeking a highly skilled Principal Systems Engineer to join our team. As a key member of our medical device software development team, you will be responsible for collaborating with clients to align user needs and business objectives with customer and stakeholder requirements.Key...

  • Principal Systems Engineer

    4 weeks ago

    Boston, Massachusetts, United States Warwick consulting Full time

    Job Title: Principal Systems EngineerWe are seeking a highly skilled Principal Systems Engineer to join our team at Warwick Consulting. As a key member of our team, you will be responsible for collaborating with clients to align user needs and business objectives with customer and stakeholder requirements.Key Responsibilities:Translate user and stakeholder...

  • Principal Civil Engineer

    2 weeks ago

    Boston, Massachusetts, United States Toole Design Group Full time

    About the RoleWe are seeking a highly experienced and talented Principal Civil Engineer to join our team in Boston, MA. As a key member of our engineering team, you will lead and mentor interdisciplinary teams to deliver multimodal transportation infrastructure projects in a wide range of contexts.Key ResponsibilitiesLead and mentor interdisciplinary teams...

  • Principal Test Engineer

    4 weeks ago

    Boston, Massachusetts, United States Digi Full time

    Transform the Future of IoT with DigiAt Digi, we're revolutionizing the Internet of Things (IoT) landscape, and we need a seasoned Principal Test Engineer to lead our testing efforts. As a key member of our team, you'll play a crucial role in shaping the future of IoT.Key Responsibilities:Develop and implement comprehensive testing strategies to ensure the...

  • Principal Cloud Engineer

    3 weeks ago

    Boston, Massachusetts, United States BlueSkyClarity Full time

    Job SummaryWe are seeking a highly skilled Principal Cloud Engineer to join our team at BlueSkyClarity. As a key member of our engineering team, you will be responsible for designing, implementing, and maintaining our cloud platform.Key ResponsibilitiesDesign and implement cloud platform architecture to support our product development teamsDevelop and...

  • Principal Quality Software Engineer

    3 weeks ago

    Boston, Massachusetts, United States Michael Page Full time

    Job Summary We are seeking a highly skilled Principal Quality Software Engineer to join our team at Michael Page. As a key member of our quality engineering team, you will play a pivotal role in guiding quality initiatives across the entire product lifecycle, from design to commercialization. About the Role In this role, you will act as the representative...

  • Principal Mechanical Engineer

    4 weeks ago

    Boston, Massachusetts, United States Fresenius Kabi USA, LLC Full time

    Job SummaryThe Principal Mechanical Engineer Specialist is a key member of our development team, responsible for planning, directing, and implementing designs and improvements to mechanical systems in Fresenius-Kabi products. This role involves achieving product performance goals and business objectives, while serving as the technical lead for the...

  • Staff Software Engineer

    4 weeks ago

    Boston, Massachusetts, United States BlueSkyClarity Full time

    Job Title: Staff Software Engineer - Principal ArchitectWe are seeking a highly skilled Staff Software Engineer - Principal Architect to join our team at BlueSkyClarity. As a key member of our Product Engineering team, you will be responsible for delivering key objectives that enable our product to scale, directly improving healthcare provision across the...

  • Principal Mechanical Engineer

    4 weeks ago

    Boston, Massachusetts, United States Dephy Inc Full time

    About the RoleWe are seeking a highly skilled Principal Mechanical Engineer to lead our mechanical team in the development of wearable robotics products. As a key member of our leadership team, you will be responsible for providing technical leadership and strategic direction for our product lines.Key ResponsibilitiesLead the mechanical design process, from...

  • Principal Test Engineer Associate

    4 weeks ago

    Boston, Massachusetts, United States Quantech Services Full time

    Job Title: Principal Test Engineer AssociateQuantech Services is seeking a highly skilled Principal Test Engineer Associate to support the C3I&N Directorate at Hanscom Air Force Base, MA.Job SummaryThe successful candidate will provide Validation & Verification (V&V) support services in accordance with the program's integrated Test Plan, program...

  • Senior Software Engineer

    3 weeks ago

    Boston, Massachusetts, United States BlueSkyClarity Full time

    BlueSkyClarity is seeking a highly skilled Senior Software Engineer - Principal Architect to join our Product Engineering teams. As a key member of our team, you will be responsible for delivering key objectives that enable our product to scale, directly improving healthcare provision across the world.Responsibilities:Lead a product engineering team to...

  • Principal Research Machine Learning Engineer for Academic Program

    3 weeks ago

    Boston, Massachusetts, United States Motion Recruitment Full time

    Job Title: Principal Research Machine Learning EngineerBoston, MAHybrid Full Time$150k - $150kAbout Us: An academic program dedicated to advancing research in machine learning and artificial intelligence is seeking a highly skilled Principal Research Machine Learning Engineer to lead transformative research initiatives.Position Overview: As the Principal...

  • Principal Electrical Engineer

    2 weeks ago

    Boston, Massachusetts, United States Servomex Full time

    About the OpportunityWe are seeking a highly skilled Principal Electrical Engineer to lead our electrical design efforts for the development of new technologies and products. As a key member of our team, you will be responsible for designing and delivering PCBA and system test fixtures, programs, and procedures.The ideal candidate will have a strong...

  • Principal Software Quality Engineer, InstructLab

    3 weeks ago

    Boston, Massachusetts, United States Red Hat Full time

    Job SummaryRed Hat's Global Engineering team is seeking an experienced quality engineer to join our InstructLab team. As a key member of our team, you will contribute to the development of test strategies and frameworks, design and implement automated tests, and maintain and enhance test frameworks.This role requires a highly collaborative individual with a...

Principal Quality Engineer

2 months ago

Boston, Massachusetts, United States Medtronic Full time
About the Role

We are seeking a highly skilled Principal Quality Engineer to join our team at Medtronic. As a key member of our Quality Engineering department, you will be responsible for providing risk management expertise and best practices for released products and post-market activities within the Advanced Surgical Technologies organization.

Key Responsibilities
  • Evaluate product issues to ensure patient, user, and security risk are assessed.
  • Act as the lead Design Quality Engineer for post-market design changes on capital hardware and disposable products.
  • Provide comprehensive support to Post Market Development Teams with a focus on Design Quality and Risk Management.
  • Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post-market life-cycle phase.
  • Conduct health hazard assessments for fielded products.
  • Conduct Corrections & Removals assessments.
  • Collaborate cross-functionally to perform bounding/scoping for field actions and assist in field action-related regulatory inquiries.
  • Assess risks that were not previously identified, as well as potential risks associated with changes in therapy, systems, products, components, manufacturing processes.
  • Collaborate with Medical Safety and Complaint Handling to review and analyze field data, discuss the harm severity sources, and estimate the probability or harm occurrence.
  • Support Complaint trending and Severity trending signal dispositions.
  • Maintain risk management files throughout the product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation.
  • Actively communicate findings to Quality, Development, and Operations teams and escalate when the risk profile of a medical device adversely changes.
  • Assure compliance to organizational procedures, regulatory requirements, and industry standards, and timely completion of assigned corrective and preventive actions and audit findings.
Requirements
  • Bachelor's degree required.
  • Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.
  • Excellent communication and technical writing skills.
  • Experience in Manufacturing and/or Electro-Mechanical Medical Devices.
  • Leadership-level domain expertise in a technology discipline within Engineering, Research & Development, or Sustaining existing technology/products.
  • Six-Sigma greenbelt or blackbelt certification.
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC).
  • Understanding of Risk Management in accordance with ISO 14971.
  • General understanding of Design controls in accordance with ISO 13485.
  • General understanding of GMP/GDP.
  • Familiarity with Supplier Qualification activities.
  • Experience with front room and/or back room compliance audit support.
  • Familiarity with Statistical analysis (capability, TMV, appropriate sample size determination).
  • Ability to interact with cross-functional team members across multiple sites to create partnerships.
  • Proven track record in identifying, evaluating, planning, and executing solutions to complex technical problems across more than one product line, business, or geography.
What We Offer

Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees' lives is at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.