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

She/He will work closely with other Fluxus teams and will help develop, optimize and use highly specialized manufacturing equipment, methods, and materials to produce optical assemblies, biochips, and other assemblies. The successful applicant will also use instruments and tools to execute diagnostic tests and QC tasks to ensure the quality of parts and reagents. She/He will work within a multidisciplinary team of engineers, scientists, and manufacturing personnel. Some of the activities might be conducted in a clean-environment setting.

Principal Duties and Responsibilities

• Develop tools, fixtures, and automated manufacturing equipment to support manufacturing scale up efforts, including QC methods and procedures
• Develop documentation to support the procurement, development and implementation of manufacturing / QC equipment and fixtures
• Develop and execute qualification/validation protocols and produce reports
• Develop protocols and conduct experiments related to process development/optimization as well as product and process specifications, etc.
• Participate in the development and maintaining of equipment controls and asset management including calibration and PM
• Support activities related to the implementation of a quality management system
• 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
• Develop and maintain accurate documentation of concepts, designs, drawings, and processes, etc.
• Participate in design transfer from product development to manufacturing.

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 the medical device, knowledge of 21 CFR Part 820 and ISO13485 requirements.
• Experience in assembling high-precision parts
• Experience in using and applying diverse types of assembly equipment, such as e.g. mechanical assembly jigs, UV-adhesives, and plasma cleaning
• Proficient in using 3D software (Inventor, Solidworks etc.) and GD&T. Knowledge/experience using CAM software (e.g. Fusion 360, Mastercam) are also a plus
• Excellent presentation and written/verbal communication skills and 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

• Plastic consumable manufacturing experience and injection molding.
• Experience with microfabrication.
• Experience using LabView, Python.
• Experience using JMP, Minitab.
• Experience working in a fast paced, small startup environment.

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.