Fluxus Inc. is seeking a highly motivated Manufacturing Engineer with hands-on experience in the medical device/biotech industry. The individual will be part of an interdisciplinary team and will play a key role in the manufacturing, fixture design, process development and production scale-up activities related to a novel diagnostics platform.

Specific skills include:

• Solid background in medical device/biotech manufacturing
• Hands-on with demonstrated process development experience.
• Establishing process flow and production line layouts
• Equipment design and selection skills
• Process development skills using statistical analysis.
• Project management experience
• Technical interface with critical suppliers

Responsibilities include but are not limited to the following:

• Provide day-to-day technical support and troubleshooting for manufacturing.
• Develop and maintain accurate documentation of drawings, BOMs and processes, etc.
• Design and develop tooling and fixtures to support manufacturing stabilization and scale-up.
• Develop and execute process qualification/validation protocols and reports.
• Interface with suppliers and contract manufacturers.
• 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 two years in a manufacturing engineering environment
• Experience in medical device, knowledge of 21 CFR Part 820 and ISO 13485 requirements.
• Proficient in using Solidworks.
• 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, with a strong work ethic and a proven ability to work in a team-based environment.

Other beneficial skill sets

• Experience using Minitab.
• Lean Six-Sigma Principles
• Plastic and silicone injection molding

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 would 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.