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Senior Regulatory Engineer

 
Full-time
Based in Salt Lake City, Utah

Blackrock aims to provide Best of Class approved neurosciences tools to the research community to push the boundaries of human applications. We are a high-tech company that continuously innovates to empower researchers to better understand the brain.

We also aim to be the provider of implantable neural interfaces to restore function to people with neurological disorders. Blackrock already delivers some of the most critical components of leading BCI set-ups. We spend every day building technology that will benefit patients suffering from paralysis disorders, neurological diseases (ALS, Alzheimer’s, Parkinson’s), and neural dysfunctions (epilepsy, brain trauma).

Join us in the challenge and contribute the following:

What You Will Love Doing

    —Serve as a resource to the engineering staff during product development and provide technical direction with respect to applicable standards
    —Review software and hardware design requirements and offer improvement recommendations as related to regulatory compliance
    —Generate and review regulatory compliance test plans & results to support regulatory submissions. Function as a mentor for research and development engineers regarding techniques to achieve safety, quality and product robustness
    —Coordinate regulatory testing with external laboratories
    —Propose, design, and conduct tests to validate and verify product design features
    —Coordinate with other engineers and other functional areas; i.e. manufacturing to accomplish design integration, prototypes, etc.
    —Participate with innovation team and client groups/teams formed to examine and evaluate technologies, procedures, and processes and make recommendations
    —Perform statistical analysis of test results
    —Remain current and knowledgeable of all compliance standards applicable to domestic/international agencies
    —Generate design files for products
    —Mentor and manage Jr. Regulatory Affairs Specialist
    —Responsible for activities such as regulatory compliance testing which lead to and maintain domestic and international regulatory compliance for medical devices
    —Responsible for assessment of device changes for regulatory implications and regulatory submissions (FDA & CE)

What You Will Bring

    —B.S. (or higher) in Electrical Engineering or other Engineering discipline required
    —5-10 years minimum of progressively more responsible experience related to product development/product evaluation as it relates to process / quality /regulatory compliance
    —Five or more years demonstrated experience and expertise in achieving worldwide regulatory requirements relating to medical electrical equipment
    —Working knowledge of regulatory compliance processes involving regulatory bodies/standards such as FDA, Health Canada, and the European Medical Device Directive
    —Working knowledge of standards for medical electrical equipment development such as biocompatibility, sterilization, risk management, and quality management systems including IEC 60601, ISO 10993, ISO 11135, ISO 14971, and ISO 13485
    —Reasoning Ability: Ability to define problems, interpret data, establish facts, and draw valid conclusions. Apply principles of logical or scientific thinking to a wide range of conceptual and practical problems
    —Technical skills: Ability to propose, coordinate, and direct tests to verify product compliance, performance, quality, and robustness. Remain current on relevant standards to support product compliance testing for both new and existing products. Strong working knowledge of safety testing equipment and techniques for the purpose of safety and environmental compliance testing
    —Strong interpersonal skills: Function as a “team player” and work constructively and cooperatively with all departments in the interests of the business. Effectively communicate with all organizational elements and motivate people in a positive, constructive manner
    —Good organization skills: must be able to manage multiple tasks and prioritize workflow while working independently
    —Working knowledge of Microsoft Suite (Word, Excel and PowerPoint) required. Strong Excel skills required including VLOOKUP, Pivot Tables, and statistical analysis

What We Will Give You

    —Access to a diverse, multicultural and caring family-like team
    —The challenge of fitting various employee and company organized events (hike, bike, football [soccer], volleyball, gaming…) into your working day
    —A free bike/ski helmet
    —Fantastic facilities with showers, bike parking and a direct view of trails up the Wasatch Front
    —Medical, vision and dental insurance
    —Life and AD&D insurance
    —Short and long-term disability insurance
    —Flexible vacation/sick leave
    —Paid maternity, paternity and adoption leave
    —401(k) with generous matching and immediate vesting
    —An opportunity for personal development and a career that will impact other people’s lives in a fundamental way

To apply, send your resume and cover letter to jobs@blackrockmicro.com.

Blackrock Microsystems is an equal opportunity employer. All qualified applicants will received consideration for employment without regard to color, disability status, national origin, race, religion, sex, or age. However, applicants must be currently authorized to work in the United States on a full-time basis.

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