Position Title: Research Scientist II

Location: South Portland, ME

Must be able to work on a W2

We have an exciting opportunity for a Research Scientist II, focused on technical documentation, within the Research & Development team at our Rapid Diagnostics business located at Scarborough, ME. In this role, you will help support on market products for the BinaxNOW™ and ID NOW™ platforms by supporting the development and creation of high-quality written content for internal and external audiences.

RESPONSIBILITIES

• Participate in a Quality Management Systems Program, with the primary responsibility being the creation of high-quality written content to support regulatory submissions.
• Daily interaction with technical documentation, documentation tasks to be performed with high-throughput and attention to detail
• Required to proofread, prepare, create, review, edit, and/or update Quality and Technical Documents including, but not limited to: SOPs, Design Control Documentation (Design and Development Plan, Customer Requirements, Product Requirements, Design Outputs, Design Verification Protocol and Reports), Technical Reports, Risk Management Documentation including FMEAs
• Understands and is aware of the quality consequences which may occur from the improper product performance; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities
• Plans and works on projects of moderate complexity under limited to no supervision
• May have supervisor duties for small teams and may direct staff in their day to day work and assist in problem solving.
• Demonstrate technical proficiency in general laboratory techniques
• Conduct experiments of a varied nature in support of on-market products
• Works with multidisciplinary team including other scientists, researchers, and technicians.
• Analyze experimental results and provide written reports and oral presentations to executives
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
• Carries out duties in compliance with established business policies
• Adapt rapidly to a changing industry and be able to adjust responsibilities, time and objectives accordingly
• Perform other duties & projects as assigned

BASIC QUALIFICATIONS

• Bachelor's degree in Biology, Biochemistry or Chemistry, or related technical field
• Minimum of 5 years of progressively responsible positions in a research development environment with laboratory and technical writing experience working under design control and developing human in vitro diagnostic tests for commercialization in the U.S and OUS
• Ability to work as part of a team with excellent communication skills
• Problem-solving skills combined with analytical skills and attention to detail
• Experience owning the end-to-end documentation creating process
• Proficiency with Microsoft Office, specifically in Word, Excel, and PowerPoint
• Must be able to productively generate quality documentation to meet program timelines

COMPETENCIES

• Project planning
• Team leadership
• Comprehension of scientific literature and terminology
• Practical laboratory skills
• Ability in mathematics and computer literacy
• Good communication skills, capable of communicating ideas to colleagues and customers
• Problem–solving skills and good organizational skills
• Understanding of the commercial value of their work
• Firm knowledge of science and the ability to apply basic principles and techniques.

Term and Start

• 6 month contract
• On-site in South Portland, Maine
• Pay rate: $35-40/HR Based on experience