Manufacturing Engineer II

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 is a leader in optofluidics that provides systems and solutions to advance the detection, diagnosis, monitoring, and treatment of disease. Our expertise lies in the interface of advanced photonics, MEMS, engineering, assay development, and reagent manufacturing excellence. We seek to close a major gap in clinical research and diagnostics by bringing our groundbreaking ultrasensitive detection technologies and assay solutions to researchers, clinicians, patients, and key industry players through strong partnerships and a future-proof portfolio of innovative products.

Fluxus was founded in 2016 and acquired in 2022 by Fujirebio Holdings, Inc., an R&D-driven company developing novel IVD technologies and biomarkers with high clinical value.

Today, as a wholly owned subsidiary of Fujirebio, Fluxus represents a unique blend of Silicon Valley startup ingenuity with the stability and reach of an established multinational corporation. Our experienced, multidisciplinary team draws on deep and varied expertise to continuously innovate and drive towards our goal of becoming the gold standard in single molecule counting and ultrasensitive biomolecular testing.