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    Hardware Engineering Manager - San Francisco, United States - Element Science Inc

    Element Science Inc
    Element Science Inc San Francisco, United States

    2 weeks ago

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    Description
    MANAGER, HARDWARE ENGINEERING

    Element Science, Inc.

    is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home.

    By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients.

    Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the US with an elevated temporary risk of potentially experiencing a lethal heart rhythm.

    Based in San Francisco and Redwood City, California, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.


    SUMMARY OF ROLE:
    The Hardware Engineering Manager, is a hands-on leader who is technically excellent, operationally savvy, and collaborativecross-functionally.

    The Hardware Engineering Manager, is responsible for leading Electrical Engineering and ensuring that the team meets Element Science's needs across all stages of product development including requirements definition, systemarchitecting, prototyping & formal design, informal formal testing, commercialization, and sustaining engineering.


    RESPONSIBILITIES:


    Lead a team of electrical engineers in all phases of product development from research through commercialization& sustaining, across multiple projects.

    Participate in strategic planning for new product development and support of the existing commercial product.

    Develop and manage project plans, ensuring cross-functional alignment on project objectives, activities,milestones, timelines, and resourcing.

    Provide technical direction in the development and/or refinement of user needs, product requirements, andhardware requirements for new products.

    Provide technical direction in the development of risk analyses and mitigations; leading risk managementdiscussions as needed.

    Provide technical direction for issues related to design, user experience, manufacturing, supply chain, etc. asneeded, leveraging risk-based decision-making skills to drive plans and/or solutions.

    Be a subject matter expert in quality system and regulatory audits as needed.


    Plan and manage electrical engineering team resourcing, adjusting priorities as needed to meet company needs fordevelopment projects as well as support of products through clinical trials and/or commercialization.

    Continuously improve engineering best practices and mentor team on Design Control, quality systems, and risk-based decision making.

    Provide mentorship and coaching to foster professional growth within the electrical engineering team.


    Foster productive collaboration within Engineering and cross-functionally by seeking to understand differentperspectives and leading constructive discussions when there are differences of opinion.


    QUALIFICATIONS:
    Bachelor's degree in electrical engineering or equivalent, advanced degree preferred.


    A minimum of 8 years relevant engineering experience, with a minimum of 2 years management experience ofdirect reports strongly preferred.

    Experience in leading Class II or Class III medical device product development of electro-mechanical devices. ClassIII experience strongly preferred.


    First-hand experience with design of products with sensitive analog electronics (and preferably also high voltageelectronics), characterization testing, verification testing, and design for manufacturability.

    Well-versed in product development standards and processes, particularly 21CFR Design Controls,ISO13485, and ISO14971.

    Experience working with test labs for IEC 60601 standards.


    Experience planning and executing cross-functional projects, with the ability to anticipate regulatory concerns andcross-functional perspectives and the ability to drive collaboration and compromise when needed.

    Experience with quality systems and procedures, with the ability to navigate procedural ambiguity common to a
    start-up environment.

    Experience leading risk management activities (e.g., system level risk analyses, DFMEAs)

    Experience supporting FDA and ISO audits strongly preferred.

    Proficient with risk-based decision-making, incorporating technical, clinical, and business risks.

    Excellent communication and cross-functional collaboration skills, with the ability to explain complex technical
    concepts to a non-technical audience and the proclivity to simplify problems and solutions.


    BENEFITS:
    Element Science offers a very competitive salary and benefits package including, but not limited to:

    Stock Options

    90% employer-paid medical, dental, and vision insurance

    Company-paid Basic Life Insurance

    401(k) retirement plan (Traditional and Roth)

    Competitive Paid Time Off

    Paid Holidays

    FSA (Flexible Spending Accounts)

    HSA (Health Savings Account)

    Employee Assistance Program through PEO

    The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

    Salary Range:
    $150,000-$174,000 + Annual Bonus + STOCK OPTIONS

    Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question.

    We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.


    In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

    We are not able to sponsor individuals for employment visas for this job.

    At this time, we are unable to offer relocation assistance at Element Science.

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