Scientist - Product Technical Support

Position Overview

This position requires relocation to Tucson, AZ.

The Scientist, Product Technical Support (PTS) in Technical Operations is responsible for performing complaint investigations, corrective and preventive actions, and product manufacturing and testing support to achieve company goals.  They will contribute to the analysis of data to identify root cause, and recommend corrections and corrective / preventative actions for on-market product issues.

Essential Functions:

• Support the Operations department (investigate and resolve QC testing issues, raw material supplier changes, etc.).
• Lead cross-functional root cause technical investigations and write investigation reports per IVD regulations.
• Prepare data reviews and participate with cross functional teams within or outside R&D.
• Manage, plan, and execute CAPAs and product / process improvement projects.
• Well versed in design control procedures, good documentation practices and good manufacturing practices for in vitro diagnostics or medical device industry.
• Good understanding of product and process risk assessments; participate in product risk analysis, dFMEA and pFMEA.
• Ability to work independently and/or lead and participate in team projects.
• Apply scientific principles and techniques to tasks and experiments.
• Guide Research Associates and Associate Scientists on daily tasks.
• Lead data collection, organization and interpretation to support senior members of the team in drawing conclusions to continue project work or adapt product design.
• Maintain records associated with complaint investigations and Medical Device Reports as required for regulatory compliance.

Qualifications & Skills

Formal Education / Relevant Experience:

• Bachelor’s degree in microbiology, biochemistry, chemistry, molecular biology or a related field plus 6 years’ related work experience.  Advanced education preferred (Master’s degree plus 4 years’ experience, or PhD plus 2 years’ experience).
• Experience in vitro diagnostics or medical device industry or equivalent, desired.

Knowledge, Skills, and Abilities:

• Understanding of lab safety
• Excellent written and verbal communication skills
• Computer skills including Windows, Word, Excel, and PowerPoint
• Detail oriented with excellent organizational and time management skills
• Ability to manage key tasks in a fast-paced environment
• Must be a self-starter, proactive, collaborative, and proficient at working both independently and in a small team environment
• Strong laboratory skills, preferably industrial microbiology
• Analytical and critical thinking skills, problem-solving skills, and decision-making ability.
• Drives cross-functional development tasks
• Proficient with JMP/R/Python or equivalent
• Intermediate experience with resolution of deviations/non-conformance reports and CAPAs
• Works well within a team environment
• Experience with root cause analysis methodologies like fishbone diagrams, 5 Whys, etc.

• Good interpersonal skills.  Ability to build relationships within the department and across the company.