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Date Added: Fri 04/06/2021

Sr Scientist/Bioengineer

San Diego, CA, US
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Company: BIOPHASE SOLUTIONS

Job Type: Permanent, FullTime

Job Description
Looking for a Senior Bioengineer to join our team in the Mira Mesa area of San Diego. The Senior Bioengineer provides technical expertise to the design and development of new and novel medical device product(s). Designs and implements new methodologies, materials, machines, processes, or products. Develops new concepts from initial design to market release. Conducts feasibility, development, verification and validation studies of the design to determine the product's ability to function as intended. Maintains detailed documentation throughout all phases of research and development. Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.


ESSENTIAL FUNCTIONS:

  • Participates in the creation of the company's technology roadmap and future product/platform planning
  • Tackles "class problems" that affect multiple products
  • Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. Exercises independent judgment in methods, techniques, and evaluation criteria for obtaining results. Creates formal networks involving coordination among multiple cross disciplinary groups
  • Defines new or special assignments to better product performance
  • Has a detailed understanding of device components or processes and overall usage intent.
  • Generates new IP and/or processes to improve function. Understands marketing/regulatory needs and knows technology landscape
  • Uses knowledge of landscape to drive new technology. Addresses future concepts, products or technologies in the context of today's issues
  • Carries out duties in compliance with established business policies and best practices in the industry
  • Perform other duties & projects as assigned
  • Experience in constructing and executing controlled experiments as part of the development process for a cartridge-based immunoassay, bringing together material science, microfluidics and thermodynamics considerations
  • Identification and optimization of plastics, surfaces, particles, interface monolayers as necessary to ensure assay performance and reproducibility goals are met
Job Requirements

Experience and Education

  • BS degree in biochemistry, chemistry, physics, bioengineering, related field, or equivalent and 10 years of related experience or, Master's degree in biochemistry, chemistry, physics, bioengineering, related field, or equivalent and 8 years of experience or, PhD or equivalent with related research work in area related to assay development or system or device engineering and 4 years of related experience
Skills and Knowledge

  • Experience with biological samples such as plasma required.
  • Successful cartridge-based immunoassay development experience required
  • Understanding of the overall cartridge design process in terms of its manufacturability and balancing trade-offs between cost and overall assay performance requirements.
  • Excellent engineering acumen for the design, development, validation and deployment of novel POC assays
  • Able to model products from concept to finished design in CAD
  • Experience with creating or modifying an entire manufacturing process to make product, from start to finish, with Design for Manufacture (DFM)top of mind
  • Experience with development of diagnostic products using biomarkers in the Point of Care setting
  • Excellent conceptual, analytical, and problem-solving ability
  • Experience with Design for Manufacturability and Assembly (DFMA)
  • Excellent computer skills -Statistical applications (Minitab, JMP), CAD, word processing, and spreadsheets.
  • Good communication skills, both verbal and written and the ability to effectively interface within a cross-functional team environment
  • Experienced In modern manufacturing principles and techniques
  • Knowledge and experience in CGMP requirements and preferably FDA and ISO 9000 requirements
  • Six Sigma/DFM/Black belt experience is desirable
  • Working knowledge of medical device regulatory requirements and standards and the ability to apply these during the development process
  • Demonstrate knowledge to evaluate the interface of chemistry, materials, fluidics and molded/machined part design
  • Ability to attract, retain and motivate a highly skilled technical group
  • Strong leadership skills and the ability to foster strong interpersonal relationships between groups
  • Knowledge of the budgeting process, planning, and building realistic timelines
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

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