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Posted: Thursday, February 1, 2018 12:04 AM

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Sr. Principal Engineer
Alucent Biomedical
Salt Lake City, UT 84101

Job Description

Alucent Biomedical is an early-stage, medical device company planning to bring game changing technologies to the clinic to improve patient outcomes. Our technology, a major advancement in the treatment of peripheral vascular disease, has the potential to eliminate the need for vascular implants and could greatly reduce the need for retreatment. We are assembling a multi-disciplinary team of physicians, engineers, chemists, biologists and material scientists, working in close collaboration to understand the biology of vascular diseases and to create solutions that address some of today’s most challenging and critical unmet medical needs.
We are looking for a self-starter, experienced at developing solutions for challenging problems.

Responsibilities

• Lead and contribute to multidisciplinary project teams in the design, development and manufacturing of devices for vascular disease and related products and processes to fulfill clinical needs within regulatory requirements
• Apply comprehensive & diverse knowledge of engineering principles to a broad range of assignments and contribute inventions, new designs, new processes and techniques to solve technical problems based on clinical needs
• Identify and establish working relationships with outside material suppliers, OEM equipment designers, and contract manufacturers to develop designs, tooling, fixtures, test methods, and inspection methods
• Document development activities through lab notebook, design history file, reports and other records in accordance with Design Control (examples include Risk Analysis, Product Specifications, Verifications, Validations) and company procedures
• Collaborate with Regulatory & Quality to ensure compliance to appropriate ISO/FDA regulations, including support of applicable regulatory submission
• Lead design reviews and project reviews
• As individual technical expert, may technically supervise other engineers or technicians

Qualifications

• B.S. or M.S. in Mechanical or Biomedical Engineering with demonstrated strength in first principal engineering
• At least 7-10 years of experience in product development for implantable medical devices focusing on product design and development through commercialization, including a minimum of 3 successful product launches
• Experience in conducting risk analysis, design verifications, and design validations
• Working knowledge of the US and international standards governing the design, development and manufacture of medical devices
• Experience developing products or commercial manufacturing under ISO or GMP procedures and associated quality system
• Experience working with Regulatory Specialists in writing documents for submission to the FDA to support clinical testing or marketing approval (e.g. IDE, HDE, 510k, PMA)
• Demonstrated skills in problem solving and applied engineering, including use of statistical tools (e.g., Minitab)
• Applied knowledge of Design Excellence/Design for Six Sigma principles, Design of Experiments (DOE) with associated tools and methods, and Design for Manufacturing
• Familiarity with Human Factors and usability studies and their impact on product development and design
• Team player who enjoys working in a highly dynamic and cross-disciplinary environment
• Excellent written and verbal communication skills
• Experience working directly with customers such as physicians, clinicians and physiologists in a treatment environment such as a catheter lab and/or an operating room

Alucent Biomedical is building a culture – an innovative, friendly and productive work environment. Other benefits include medical/dental/vision insurance, 401(k), and more.

Interested candidates should send an email to - hr@alucentbiomedical.com

Please include "Sr. Principal Engineer position" in the subject line to ensure your resume is properly recognized and reviewed.

• Location: Salt Lake City

• Post ID: 17637202 utah
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