Nanobiosym, Inc. Engineer: Manufacturing in Cambridge, Massachusetts
23-Mar-2021 to 01-May-2021 (EST)
Cambridge, MA, USA
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Nanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a recipient of multiple other prestigious peer-reviewed funding awards, Nanobiosym is currently adding to its talented team as it expands into a global commercial enterprise.
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.
Must have Bachelors of Engineering degree, mfg. preferred.
10+ years in medical device manufacturing experience in a regulated environment.
Intimately familiar with ISO13485 and 14971.
Setup a manufacturing workflow utilizing lean production methods.
Manage the installation of new manufacturing equipment, fixtures, and tools for continuous process improvement.
Must be able to qualify 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 process capability and SPC.
Individual must manage the manufacturing process, technicians, assemblers and documentation. capable to move into the management role when needed.
Responsible for the Master Validation Plan and manage its implementation.
Knowledge of validation processes such as creating validation plans, manage calibration schedules, tool management, etc.
Must be willing to be hands on and wear multiple "hats". -be ready to participate in quality systems, 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.
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.