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    Mechanical Design Engineer, Lead - Irvine, United States - Rockley Photonics

    Rockley Photonics
    Rockley Photonics Irvine, United States

    5 days ago

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    Description

    SUMMARY

    Rockley is looking for a Lead Mechanical Design Engineer with robust medical device experience in a start-up environment to be part of our team. Rockley is developing a new wrist-worn wearable device for cardiovascular sensing. Together with a close-knit team, you will lead the mechanical design of the device and the fixtures necessary to test it. You will be tasked with solving multi-disciplinary problems involving wearable optical sensing technologies by working closely with electrical and biomedical engineers. You will be responsible for transitioning designs from prototype to low volume manufacturing with an eye towards high volume manufacturing. You will also be heavily supporting the verification testing of the mechanical portions of the device.

    MAJOR RESPONSIBILITIES

    *This list is not all inclusive. Additional duties will be assigned as needed.

    Essential Duties/Responsibilities

    • Design and develop wrist-worn wearable medical devices
    • Collaborate with electrical and biomedical engineers to define requirements and understand constraints
    • Create engineering drawings, analyses, and reports
    • Develop according to medical device regulations, including US 21 CFR 820, ISO 13485, and ISO 14971
    • Identify, evaluate, and lead communication with vendors and external design partners
    • Design test fixtures for verification testing and assist in writing protocols, reports

    Required Knowledge/Skills/Abilities

    • Experience with medical device design and development
    • Design and modelling of plastic injection molded parts, metal parts, and test fixtures
    • Strong design and analysis skills in SolidWorks including Geometric Dimensioning and Tolerancing (GD&T) and Data Management (PDM)
    • Working knowledge of CAE (Finite Element Analysis, Computational Fluid dynamics)
    • Experience developing and analyzing tolerance stack ups
    • Experience with medical device risk management and drafting FMEAs
    • Strong technical skills and ability to evaluate and analyze data and results
    • Ability to work in a fast-paced environment both independently and in a group setting
    • Excellent interpersonal, verbal, and written communication skills in English

    Preferred Knowledge/Skills/Abilities

    • Experience in the development of wearable devices.
    • Understanding of optomechanical design and assembly.

    EDUCATION & EXPERIENCE

    • Minimum of a Bachelor of Science (Mechanical, BioMedical, Materials, Physics, or similar)
    • Minimum 8+ years experience in R&D or Mechanical Design Engineering or equivalent
    • Strong technical skills and ability to evaluate and analyse data and results.
    • Experience designing electromechanical assemblies for high volume manufacturing and automation
    • Ability to create test protocols to answer critical questions toward wearable product development
    • Experience in general lab technique, design of experiments, mechanical/electrical/optical equipment and setups is desirable
    • Excellent interpersonal, verbal, and written communication skills
    • Excellent computer skills with Microsoft Word, Excel, and Outlook.
    • Effective communication skills which include verbal and written in English
    • Ability to work in a fast-paced environment both independently and in a group setting with minimal direction the flexibility to adjust to workload based upon changing priorities.
    • Time management the ability to achieve results within expected time periods.
    • Problem-solving & critical thinking
    • Must maintain a professional/ positive attitude.
    • Demonstrate risk assessment and consideration of evidence with every decision, and appropriately prioritizes work.
    • Organizational Values: Customers, Results, Innovation, Excellence, Teamwork

    WORKING CONDITIONS

    Employee is required to have visual acuity to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations of equipment and facilities. Is a typical office environment. May require occasional overnight travel (<10%). Work hours may consistently exceed 40 hours a week. Must be able to meet and work under Export Control requirements.

    This position requires access to information protected under US export control laws, including the International Traffic in Arms Regulations and/or the Export Administration Regulations. Please note that any offer of employment may be conditioned on authorization to receive software or technology controlled under these US export laws without sponsorship for an export license.

    Rockley is proud to be an Equal Opportunity and Affirmative Action employer. We do not discriminate based upon race,racial expression, including protective hairstyles, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law.

    Rockley is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know.

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