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Nanobiosym, Inc. Engineer: Manufacturing in Cambridge, Massachusetts

Engineer: Manufacturing

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  • 23-Mar-2021 to 01-May-2021 (EST)

  • Cambridge, MA, USA

  • Full Time

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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.

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

  • 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.

  • Personal 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.

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