Senior Project Engineer (ADX-296-20)
Senior Project Engineer (ADX-296-20)
COMPANY SUMMARY:
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
POSITION SUMMARY:
The Project Engineer develops, supports and executes processes within the operations engineering team. The operations engineering group transitions, stabilizes and improves processes critical to the maintenance and production of ArcherDx’s regulated products. This role is a key interface between R&D, Operations, Quality and Regulatory. The project engineer may lead, support and execute projects of either a technical or compliance nature.
RESPONSIBILITIES:
Job performance will involve a variety of activities including:
- Identifying tasks and work break-down, Execution of tasks
- Developing schedule and tracking progress
- Managing cost
- Identify resource gaps
- Coordinate with vendors
- Reporting to management
EXPERIENCE:
- 8 Years of experience in a regulated environment (IVD, Medical Device, or Pharma)
- Experienced navigating quality systems, process improvements, manufacturing.
- FDA CFR 820, ISO 13485, ISO14971
KEY ATTRIBUTES:
- Drive and determination
- Ability to work in a fast paced and dynamic environment
- Organization, attention to detail and problem-solving skills
- Ability to use specialized software for collaboration and time management
- Experience in process improvement
- Strong time management and analytical skills
- Firm understanding of complex mathematical concepts
- Proven leadership skills\Mentoring
- Strong communication skills
- Self-starter
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
EDUCATION:
- BS/MS Engineering