You will work with the direction of the Product Development Manager as an integral part of the new Development team in a fast-paced environment to develop and bring to market molecular diagnostic tests for detection of circulating tumor DNA in blood. This team supports the existing commercial test (Colvera TM) and is also responsible for the improvement & development of current and new tests, respectively.

You will be creating and maintaining all operation documentation in compliance with medical device regulations. Essential to this role are relevant scientific training, commitment to quality, a strong work ethic, attention to detail and good documentation practices. The ideal candidate must have experience working in regulated environments. Visit http://clinicalgenomics.com/ for more information.


Essential Responsibilities include but not limited to:

  • Support all development processes and documentation related to regulatory approval of Class III IVD assay
  • Develop & maintain operation documents and records (production SOPs, component specifications, verification/validation protocol and reports)
  • Lead and/or support product development and design activities throughout the product lifecycle
  • Establish and maintain design history file
  • Create and maintain individual project timelines and budgets
  • Create and maintain product and process risk management files according to US and international regulations (following corporate QMS)
  • Provide routine updates to the project and executive management team
  • Resolve process/product related NCRs and CAPAs in compliance with corporate QMS
  • Provide support for open supplier related NCRs and CAPAs in compliance with corporate QMS.
  • Support improvement initiatives


Qualifications:


  • Authorization to work in the US indefinitely without restriction or sponsorship.


Education

  • Bachelor’s degree (Master’s preferred) in a scientific or technical discipline such as Chemical, Mechanical, Process Engineering, Biomedical Engineering, or similar.


Experience

  • 5-10 years experience in the medical device industry, preferably IVD in a product development position with a strong focus on design controls and documentation.
  • High-level technical writing skills and documentation experience including: protocol design, execution and reporting.
  • Comprehensive knowledge of process development and validation,
  • Strong Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices and other international standards and regulations.
  • Process troubleshooting, root cause analysis with deep knowledge of root-cause analysis methods.

 

Skills/Knowledge/Cultural Fit

  • Outstanding analytical and problem-solving skills
  • Fact-driven and Result oriented, Diligent, methodical
  • Highly detail oriented with effective time management, scheduling, and organizational skills
  • Excellent communication and stakeholder management skills
  • Very sound manufacturing knowledge
  • Experienced with design transfer, including packaging, labelling, and DMR writing
  • Excellent knowledge of Microsoft office suite including advanced knowledge in excel
  • Very good understanding of statistical methods and analysis.
  • Leadership experience of risk management activities (preferable)
  • Knowledge or familiarity with molecular biology is desirable.
  • Must be flexible, innovative, and self-motivated
  • Ability to be highly productive and thrive in a high paced work environment.

 

Job Type: Full time

Location: 1031 US Highway 202/206, Bridgewater, NJ 08807

Authorization: Unrestricted authorization to work in the US indefinitely.

 

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