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    Engineer II R&D - New York, United States - Planet Pharma

    Planet Pharma
    Planet Pharma New York, United States

    3 weeks ago

    Default job background
    Description
    R&D Engineer II

    • Prior experience as a sustaining engineer (R&D) in a medically regulated industry (Class II or III highly preferred)
    • Design verification and validation experience in the medical device industry
    • Basic understanding of Solidworks CAD system
    • Exposure to failure mode analysis.
    • PPK, MLTL, or any base level knowledge of statistical tools or analysis (Minitab use).
    • Test method validation
    • Design verification (plans & protocols), reporting, and testing
    • Data failure analysis on the design verification testing

    What will not work:

    • Manufacturing or Quality engineer backgrounds
    • Candidates with less than 3 years of experience
    • Candidates without medical device experience

    Please target candidates w/:
    3 plus years of relevant work experience with a Bachelor's, Master's preferred


    Schedule:

    • Standard office hours, potential of overtime but not likely to exceed 5 hours.

    Location:

    • Irvine, CA campus (full time onsite)

    Job Description:
    Applies knowledge of technical principles and systems/procedures to maintain and optimize CC legacy products.

    Essential Job Functions:

    Test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles 25% Generate work instructions, test methods, engineering drawings/prototypes, etc.

    to establish/ characterize product and/or process specifications 25% Create/update portions of design control documents including requirement specs and risk documents 20% Assign R&D support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work 15% Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers 10%

    Required Skills:
    Good computer skills in usage of MS Office Suite; CAD experience preferred
    Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
    Basic understanding of statistical techniques
    Previous experience working with lab/industrial equipment required (if applicable)
    Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
    Solid problem-solving, organizational, analytical and critical thinking skills
    Solid understanding of processes and equipment used in assigned work
    Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
    Strict attention to detail
    Ability to interact professionally with all organizational levels
    Ability to manage competing priorities in a fast paced environment
    Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
    Ability to build productive internal/external working relationships
    Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

    Level of Independence:
    Works independently without close supervision
    Compares and evaluates possible courses of action after considering various possibilities
    Applies his or her knowledge in following procedures or in determining which procedures to follow or
    determining whether specified standards are met
    Considers the cause and effect of activities exhaustive, and which allow room for creativity and judgment
    Direction tends to be high level and focused on end results with means of accomplishment left to incumbent

    Education/Experience:
    Bachelor's degree in engineering required. Master's degree preferred.
    3 + years experience required.
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