Manufacturing Assembler - Nanobiosym

Nanobiosym is dedicated to creating technology platforms at the interface of physics, medicine and nanotechnology. Nanobiosym Diagnostics, Nanobiosym 's commercial engine, focuses on the commercialization of its disruptive diagnostic technology platform, which will empower people worldwide with rapid, accurate, and portable diagnostic information about their own health. Nanobiosym was founded by an MIT/Harvard alum and is comprised of a world class team of Directors, Advisors, and Strategic Partners. This hyper growth company allows for unique career opportunities with strong long-term incentives.

Our Mission is to democratize access to basic health care, empower the health care consumer, and ultimately transform the overall health care experience.

DUTIES

Nanobiosym is seeking strong candidates to work in a dynamic team environment of physicists, engineers, and other multidisciplinary scientists. The job responsibility will primarily include developing, designing, troubleshooting manufacturing SOP's.

 Qualifications:

• Ideal candidate must have 10+ years experience in medical device manufacturing in a regulated environment.
• Familiar with ISO13485 and 14971.
• Must be able to verify mfg documentation and manage changes or corrections.
• Manage device history records and documentation.
• Knowledge of a manufacturing workflow utilizing lean production methods.
• Assist in the installation of new manufacturing equipment, fixtures, and tools for continuous process improvement. 
• Understanding of qualification of equipment and processes (IQ, OQ, PQ)
• Identify cost reduction opportunities and implement cycle time improvements.
• Manage production workflow and yield. Maintain productivity metrices.
• Must have experience with data collection, process capability, and SPC.
• Individual must be able to manage the manufacturing process, fellow technicians, assemblers and documentation. capable to move into the management role in the future.
• Manage calibration schedules, tool management, etc.
• Must be willing to be hands on and wear multiple "hats". -be ready to participate in quality meetings, engineering, regulatory activities, etc.
• Individual would be a motivated, self-starter who handles multiple projects at the same time.
• Candidate must thrive in a startup organization poised for growth.
• Willing to work in a security conscious environment.

 

ersonal Qualities:

The ideal applicant will be:

Excited to work in a hypergrowth company;

Able to work 6 days/week; immediate start date

Extremely motivated and be willing to work in a fast-paced environment with a hard-working team;

Committed and enthusiastic about Nanobiosym's mission;

Resourceful and flexible;

Adept at planning, prioritizing, multi-tasking, organizing and following through, while remaining highly energetic and focused;

Straightforward, self-motivated, and trustworthy;

Energetic and willing to work hands-on in developing and executing a variety of activities.