Senior NPI Engineer

Sunnyvale, CA

Fluxus Inc. is seeking a highly motivated Senior NPI Engineer with hands-on experience in diverse manufacturing engineering related tasks within the biotech industry. He/She will be part of an interdisciplinary team and will play a key role in the development, execution, and implementation of new products, transfer to manufacturing, fixture design, process development, production scale-up activities as well as being a key stakeholder in developing the quality system related to a novel diagnostics platform.

Specific skills include:

  • Design Control and new product transfer experience
  • Design for Manufacturability
  • Leading product development teams in process development and validations
  • Establishing process flow and production line layouts
  • Equipment design and selection skills
  • In-depth process development skills using statistical analysis
  • Solid background in medical device/biotech manufacturing
  • Project management experience
  • Technical interface with critical suppliers

Principal Duties and Responsibilities

  • Lead design transfers from product development to manufacturing
  • Develop and maintain accurate documentation of concepts, designs, drawings, BOMs and processes, etc.
  • Develop tools, fixtures and automated manufacturing equipment to support manufacturing scale up efforts, including QC methods and procedures
  • Develop protocols and conduct experiments related to process development/optimization as well as product and process specifications, etc.
  • Develop and execute qualification/validation protocols and reports
  • Develop and maintain relationships with suppliers and contract manufacturers
  • Participate in and lead risk management activities (ISO 14971 and/or FMEA)
  • Perform data analysis and develop/present presentations/reports

Minimum Education and Experience Requirements

  • BS degree in Mechanical or Biomedical Engineering or a related field with a minimum of 5-7 years in a manufacturing engineering environment
  • Experience in medical device, knowledge of 21 CFR Part 820 and ISO13485 requirements.
  • Experience in assembling high-precision parts
  • Proficient in using Solidworks, GD&T
  • Excellent presentation and written/verbal communication skills
  • Experience working in a fast paced, small startup environment
  • Knowledgeable in Good Documentation Practices (GDP)
  • Detail-oriented, motivated, thoughtful, and with a strong work ethic and a proven ability to work collaboratively in a team-based environment

Other Beneficial Skill Sets

  • Experience using JMP, Minitab
  • Lean Six Sigma Principles
  • Plastic and silicone injection molding
  • Experience with Optical-Fluidic Chip fabrication
  • Experience with Capital Equipment
  • Experience using LabView, python

About Fluxus

Fluxus Inc. is a privately held development-stage medical device company located in Sunnyvale, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.

As a member of Fluxus’ team, you will join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

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