Job Responsbilities
- Complete daily tasks in accordance with BioIntelliSense Policies and Procedures, including the safety rules and regulations
- Must follow Good Documentation Practices (GDP)
- Responsible for work order ticket prioritization for the Service and Fulfillment team and ensuring tickets are completed on-time and with no failures
- Working alongside engineers to build and test solutions to a variety of technical problems
- Inspecting and modifying existing designs and prototypes
- Conduct tests, collect data, and record the data clearly and accurately
- Analyze operations and offer suggestions for improvement
- Maintain accurate records and assist with data collection for metrics and presentations
- Set-up computer driven test equipment and supporting processes
- Create procedures to document the test process
- Conduct inspection of devices.
- Run diagnostics and calibrations
- Inspect inventory and reordering materials and technical components
- Support and follow all ISO 13485 standards
- Perform general 5S activities daily
- Identify and report non-conforming material and product
- Apply product traceability
- Perform packaging and labeling duties
- Retrieve information, train and transfer knowledge to team members
- Lead and positively influence others in a team-based environment
- Align with BioIntelliSense’s mission, values and leadership principles
- Other duties and special projects as assigned
Job Requirements
- 2-3 years of manufacturing and inspection experience within the medical device industry preferred
- Previous experience in an FDA and/or ISO 13485 regulated environment preferred
- Knowledge and use of relevant computer software applications and skills to use them effectively
- Sound understanding of electronics technology
- Extensive experience running computer driven test set-ups
- Excellent attention to detail and organizational skills
- Ability to work independently but also collaborate and remain calm and professional in a fast-paced, dynamic environment
- Strong communication, writing and presentation skills; Ability to read and write in English is required
- A willingness to learn and work overtime when required
- Able to foster a positive culture and collaborate cross functionally while advancing BioIntelliSense as a great place to work
Physical Requirements
- Job duties are performed in a warehouse setting. This position requires reading, hearing, close vision, walking, bending, sitting, and occasional lifting up to 50 pounds.
- The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
· We are leaders - Leadership is not limited to our management team. It's something everyone at BioIntelliSense embraces and embodies.
· We are doers - We believe the only way to predict the future is to build it. Creating solutions that will lead BioIntelliSense and healthcare industry is what we do - on every project, every day.
· We are learning - We're not afraid to dig in and uncover the truth, even if it's scary or inconvenient. Everyone here is continually learning on the job, no matter if we've been in a role for one year or one minute.
· We have great benefits - Medical/Dental/Vision/Life (at little to no cost to the employee), Disability (STD & LTD), 401(k) matching, 10 Paid holidays a year, generous vacation paid time off