Nanobiosym is an innovative nanotechnology company in Cambridge, MA that is developing point-of-care diagnostics to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine.
Nanobiosym is currently seeking a talented Manufacturing Engineer with medical device experience.
This role will include a combination of many tasks such as setting up workstations, work instructions, inspection plans, authoring documentation, data collection planning, managing equipment and tools. Defining test and assembly fixtures. Contributing to documentation required by the DHR and the QMS.
- Create and establish manufacturing workstations
- Author documentation such as work instructions, travelers, and reports
- Analyze data and document trends, performance, and create metrics.
- Handle scheduling of work.
- Develop inspection plans
- Design test fixturing
- Author and manage process validation activities
- Manage equipment and tools. Handle the preventative maintenance and calibration activities.
- Maintain inventory levels in assembly area.
- Manage production controls
- Responsible for the device history record
- Support root cause analysis for laboratory and product investigation
- Contribute to risk assessment activities and hazard analysis.
- Devise innovative approaches to engineering problems
- BS degree in Engineering, Technology or equivalent practical experience
- Must have experience and knowledge of ISO13485 and/or GMP environments.
- Experience working in highly regulated industries (i.e. automotive, aviation, or FDA)
- A life science and/or medical device industry preferred
- Minimum 5 years of manufacturing experience. 10+ years preferred.
- Past experience of quality management systems and protocols.
- Must have strong mechanical aptitude and technical sense.
- Must have an understanding of principles of statistics relevant to product manufacturing processes
- Must have an understanding of failure mode effects and root cause analysis
- Must be comfortable working in fast-paced startup environments.
- Individual must be able to manage and lead team members and technicians.
- Experience with data collection tools (i.e. labview, run automation scripts, analyze reports and issues, report bugs)
- You are passionate about testing, quality assurance, healthcare, and mobile technology
- You are methodical, detail oriented, well organized and effective at time management
- You are a self-starter
- You have good interpersonal, verbal communication, and documentation skills
- You can function well in a challenging and fast-paced environment
- You are enthusiastic and positive, with strong skills in the areas of dependability, flexibility, and maturity
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