Based in Salt Lake City, Utah
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Blackrock aims to provide Best of Class approved neurosciences tools to the research community to push the boundaries of human applications. Blackrock already delivers some of the most critical components of leading BCI set-ups. We spend everyday building technology that will benefit patients suffering from paralysis disorders, neurological diseases (ALS, Alzheimer’s, Parkinson’s), and neural dysfunctions (epilepsy, brain trauma).
Blackrock is seeking a Quality Engineer who will be an integral part of the project team as a subject matter expert on all things Quality: design controls, risk assessment, verification, validation, ISO standards, audit prep and project strategy. The ideal candidate will be involved in fast paced product design and change efforts through all product life cycles and will be an equal stakeholder in driving projects to success.
• B.S. (or higher) in Electrical Engineering or other Engineering discipline required (General STEM acceptable).
• Quality certification is a plus.
• Minimum 4 years of experience in engineering, quality, new product development, working in a highly regulated environment (Medical Device, Aerospace, etc.)
• Minimum 4 years of demonstrated experience and expertise in achieving regulatory requirements relating to medical electrical equipment.
SPECIFIC SKILLS/COMPETENCIES DESIRED
• Working knowledge of regulatory compliance to FDA (21 CFR 280), Medical Device Single Audit Program (MDSAP) countries, and European Medical Device Directive (MDD).
• Familiar on relevant standards to support product compliance, that include, but not limited to:
— ISO 10993 (Biological evaluation of medical devices – Biocompatibility)
— ISO 11135 (Sterilization of health products)
— ISO 14971 (Risk Management)
— IEC 60601 (Product Safety Standards – EMC Testing)
• Demonstrate effective communication skills across all organizational levels and motivate people in a positive, constructive manner.
• Act independently to determine methods to define problems, interpret data, establish facts, and draw valid conclusions.
• Demonstrate being detail oriented with strong organizational skills.
ESSENTIAL JOB DUTIES
• You will work in a cross-functional team to communicate adherence to design controls that relevant to regulatory requirements, standards, and guidance documents.
• You will assist in developing qualification plans, protocols, test methods, inspection criteria, manufacturing processes development, part specifications, labeling, deviations, and research product.
• You will review verification and validation test reports, drawings specifications, inspection specifications, First Article Inspection (FAI), incoming product, and finished devices.
• You will coordinate remediation tasks in a cross functional team that involve project design, manufacturing deviations, Corrective/Preventative Actions (CAPA), internal and external audits, customer complaint, and supplier evaluation.
• You will ensure approved supplier list and calibration records are up to date.
The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.