Jobs
>
Fremont

    Product Development Engineer-Orthopedics - Fremont, United States - Moximed

    Moximed
    Moximed Fremont, United States

    1 week ago

    Default job background
    Description

    Purpose and Scope

    The engineer is to work within a regulated quality system environment to further develop Moximeds joint unloading technology embodied by the MISHA Knee System. In this role you will be working with cross-functional groups. Your role will be essential in developing product improvements and verifying/validating changes against user needs, product requirements, and intended use. Must enjoy the team approach over individual contributions. Experience with product development after design transfer to production is required.

    Responsibilities

    • Build on current product and joint unloading technology following design control procedures and principles.
    • Analyze and interpret customer feedback, complaints, and retrieved products to drive and support product development activities.
    • Collect data to support the business case and design input for development projects. This includes root cause analysis, cost estimates from suppliers, and one-on-one or focus group meetings with end-users including surgeons, nurses, and other healthcare workers. The ability to assist with COGS assessments is desirable.
    • Integrate cross-functional groups early in the development and provide consistent updates.
    • Create and perform engineering validations and verifications challenge existing tolerances, mechanical testing, packaging testing, etc.
    • Perform risk-based assessments as part of development activities. Experience with developing and executing biocompatibility evaluation plans to support product and process changes is highly sought.
    • Prepare and present technical and end-of-phase design reviews to cross-functional group members.
    • Maintain accurate documentation including test protocols, reports, and engineering assessment to support quality system and regulatory requirements. Incorporation of lean documentation principles required.
    • Suggest, contribute, and champion initiatives to improve R&D, design control, and change control practices.
    • Work directly with cadavers and in an OR setting to inform on the development and refinement of hand-held surgical instruments and minimally invasive surgical techniques.
    • May require up to 10% travel to visit suppliers, end-users, etc. in addition to working on site in the Fremont facility as needed.
    • Other responsibilities may be assigned to meet the needs of Moximed.

    JOB REQUIREMENTS

    Education and Training

    • Bachelors Degree in mechanical engineering or equivalent discipline preferred.
    • 5+ years of experience in a manufacturing environment with 3+ years of actual product development experience is required. Preference is given to FDA Class 2 orthopaedic medical devices development.
    • Excellent SolidWorks knowledge and skills for the creation and revision of parametric models and ASME Y14.5 compliant engineering drawings. Ability to interpret and perform tolerance stack-up analyses highly desired.
    • Advanced knowledge of MS Office computer required. Knowledge of MS Project preferred.
    • Proven history of leading design verification, design validation, test method validation, and/or process validation (IQ/OQ/PQ) testing required.
    • Knowledge of descriptive statistics and sampling methodology is required at minimum. Working knowledge of Minitab software desirable.
    • Well versed in ISO 14971 hazard analysis. Experience with creating dFMEA and pFMEA to inform hazard analysis desirable.
    • Working knowledge of ISO 11137 radiation sterilization standards, ISO 10993 biocompatibility standards, and FDA guidance on ISO highly desirable.

    Technical Requirements

    • Excellent problem solving, strategic thinking, decision making, analytical, and oral / written communication skills required.
    • Results oriented, strong sense of ownership, and committed to achieving meaningful results.
    • Ability to work well under pressure to meet deadlines in a cross-functional team environment.
    • Ability to define problems, collect data, establish facts, and draw valid conclusions.
    • Ability to interpret an extensive variety of technical instructions.
    • Ability to work independently with minimal supervision on a daily basis.

    Managerial Experience

    • Excellent problem solving, strategic thinking, decision making, analytical, and oral / written communication skills required.
    • Must be able to work within a lean, focused R&D group and manage/collaborate with cross-functional team members to achieve milestones.
  • Moximed

    Product Development Engineer-Orthopedics

    1 day ago

    Moximed Fremont, United States

    Purpose and Scope · The engineer is to work within a regulated quality system environment to further develop Moximed's joint unloading technology embodied by the MISHA Knee System. In this role you will be working with cross-functional groups. Your role will be essential in devel ...

  • Info Way Solutions

    Developer Engineer

    4 days ago

    Info Way Solutions Fremont, United States

    Hi Professional · This is Sangeetha from Info Way Solutions; LLC We have job opening fora Developer Engineer - Crypto Services and the detailed Job description is given below: · Kindly check the JD and share your views · Title : Developer Engineer - Crypto Services · Location ...

  • Info Way Solutions

    Developer Engineer

    3 days ago

    Info Way Solutions Fremont, United States

    Hi Professional · This is Sangeetha from Info Way Solutions; LLC We have job opening fora · Developer Engineer - Crypto Services · and the detailed Job description is given below: · Kindly check the JD and share your views · Title : Developer Engineer - Crypto Services · Loca ...

  • Aurora Technologies

    Development Engineer

    1 week ago

    Aurora Technologies Bay View, United States

    At Bay View, our clients value FERCHAU for our ability to find the best minds for a variety of tasks, and for our expertise in connecting people and technology on a daily basis. Join us as an ambitious colleague who, like us, is passionate about taking technology to the next leve ...

  • NovaWorks

    A DevOps Engineer is a professional who specializes in the practices and tools used to automate and streamline the processes between software development and IT operations

    1 week ago

    NovaWorks Fremont, United States

    We are looking for a smart and motivated team member to join our Division Homeland Security at our location in Essen as soon as possible. · Your responsibilities · You will manage and expand our production infrastructure, continuously modernizing it. · You will develop automated ...

  • Apex Innovations

    Development Engineer

    1 week ago

    Apex Innovations Frisco City, United States

    The igus GmbH is a family-owned company based in the greater Cologne area. As a "hidden champion," we are an internationally operating manufacturer of technical products made from high-performance plastics. Our products are versatile and can be found in over 50 different industri ...

  • Sterling Process Equipment & Services, Inc.

    Equipment Development Engineer

    1 week ago

    Sterling Process Equipment & Services, Inc. Fremont, United States

    About the role - you will: · Collaborate with process teams to develop new materials, designs and/or processes that mitigate degradation mechanisms that results in improved reliability. · Triage issues during continuous integration & deployment process. · Design control of automa ...

  • Krzbb

    Hardware-Development Engineer

    1 week ago

    Krzbb Fremont, United States

    ... immer aktuell und kostenlos per E-Mail. · Delta Energy Systems (Germany) GmbH is belonging to Delta Electronics. Delta, founded in 1971, is a global provider of power and thermal management solutions. Its mission statement, "To provide innovative, clean and energy-efficient s ...

  • Heise Online

    Hardware-Development Engineer

    1 week ago

    Heise Online Fremont, United States

    Hardware-Development Engineer (m/f/d) · Delta Energy Systems (Germany) GmbH · Fremont (CA/USA) · ... immer aktuell und kostenlos per E-Mail. · Hardware-Development Engineer (m/f/d) · Location: Fremont/USA as Expatriate · You will work as Expat for our German Legal Entity in ou ...

  • Info Way Solutions

    Software Development Engineer

    3 days ago

    Info Way Solutions Fremont, United States

    Hi Professionals, · Hope you are doing good · This Is Jayaraman from Info Way Solutions, LLC We Have Job Opening For Software Development Engineer and The Detailed Job Description Is Given Below: · Kindly check the JD and share your views · Software Development Engineer · Bo ...

  • Viant Medical

    Product Development Engineer

    1 week ago

    Viant Medical Fremont, United States

    New employees are eligible for the following benefits effective date of hire · Medical, dental, and vision benefits · Company-paid life insurance and disability benefits · Self-managed (unlimited) PTO and 11 paid holidays · 401k Plan with Company Match · Tuition Reimbursement · C ...

  • Viant, Inc.

    Product Development Engineer

    1 week ago

    Viant, Inc. Fremont, United States

    New employees are eligible for the following benefits effective date of hire · Medical, dental, and vision benefits · Company-paid life insurance and disability benefits · Self-managed (unlimited) PTO and 11 paid holidays · 401k Plan with Company Match · Tuition Reimbursement · C ...

  • Supernal

    Engineer, Equipment Development

    1 week ago

    Supernal Fremont, CA, United States

    Supernal is at the forefront of creating emerging mobility solutions that will foster the development of human-centered cities. We are designing a completely new electric vertical take-off and landing (eVTOL) aircraft tailored to the mobility needs of future cities. This allows p ...

  • Human Bees

    Senior Product Development Engineer

    1 week ago

    Human Bees Fremont, United States

    Essential Functions: · Lead and manage product development projects through all stages of the development process. · Assess incoming product development requests. Conduct initial project feasibility, expense and risk studies. · Write detailed engineering specifications and concep ...

  • Teal Energi

    Battery Pack Development Engineer

    1 week ago

    Teal Energi Fremont, United States

    Battery Pack Development Engineer · Our client is a technology and engineering services business, which applies world-class technical innovation, engineering, testing and manufacturing services to deliver energy efficient performance. · Their team consists of experts in electrifi ...

  • Human Bees

    Senior Product Development Engineer

    1 week ago

    Human Bees Fremont, United States

    Essential Functions: · Lead and manage product development projects through all stages of the development process. · Assess incoming product development requests. Conduct initial project feasibility, expense and risk studies. · Write detailed engineering specifications and con ...

  • Lucid Motors

    Development Tools Engineer

    4 days ago

    Lucid Motors Newark, United States

    Leading the future in luxury electric and mobility At Lucid, we set out to introduce the most captivating, luxury electric vehicles that elevate the human experience and transcend the perceived limitations of space, performance, and intelligence. Vehicles that are intuitive, libe ...

  • Sila Nanotechnologies

    Materials Development Engineer Intern

    3 days ago

    Sila Nanotechnologies Alameda, United States

    Job Description · Job DescriptionAbout UsWe are Sila, a next-generation battery materials company. Our mission is to power the world's transition to clean energy. To create this future, our team is building a better lithium-ion battery from the inside out today. We engineer and m ...

  • SureStaff LLC

    Paper Product Development Engineer

    4 days ago

    SureStaff LLC Fremont, United States

    Job Description · Job DescriptionSureStaff has an exciting faced paced opportunity working on many new projects for a Paper Product Development Engineer for our growing fiber-based business This position can be located at any of our USA sites – Fremont, OH; Knoxville, TN or Beave ...

  • Stellar Innovations

    Development engineer for optical measurement technology

    1 week ago

    Stellar Innovations Pleasanton, United States

    For over 170 years, Leica Microsystems has been shaping the future of microscopy with groundbreaking optical and digital solutions. As a global leader, we are committed to continuous improvement to delight our customers and create the best working environment for our employees. C ...