Job Details

  • Title: Scientist / Project Manager
  • Code: RCI-18899
  • Location: Saint Paul, MN 55117
  • Posted Date: 11/23/2021
  • Duration: 12 Months
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  Job Description

  • Available to travel to the CRO’s and initiate testing to maximize project success.
  • Protocol report writing and approval
  • Time management and coordination with external partners
  • Expert in Extractable and Leachable analysis specially with metal leachable design
  • we have a number of product containing cobalt and nickel
  • LCMS tools, GCMS and FTIR
  • Looking for Sr scientist / Project Manager role
  • Local candidates only
  • Supporting EUMDR for structural heart team
  • work cross functional with materials group
  • ICP or ICP/MS exp needed
  • Working with other Project Managers
  • Making sure study design for leachable is written correctly
  • Masters with 4 yrs. and Ph.D. with 2 yrs. exp

Top Skills

  • Exp working with outside testing labs and submitting requests
  • Some PM exp or familarity with managing projects
  • ICP/MS exp

Scientist Senior - Extractable and Leachable

  • The senior scientist will act as a liaison between the biocompatibility group and chemistry team to provide chemistry support for all external chemical characterization studies being executed.
  • This position will partner heavily with a project/product manager and biocompatibility as well as our outside testing partners to assure the chemical characterization studies are executed to the current standard and to client’s expectations.
  • A solid knowledge of ISO 10993-12 and 18 and the FDA’s expectations of chemical characterization is needed.

Primary Responsibilities

  • Familiarity with Leachable study design for external extractable & leachable (E&L) studies
  • Trouble shoot and align external partners E&L study design execution
  • Confirm the outside lab can meet our requirements for testing
  • Good time management and Coordination with external partners regulator response strategy
  • Communicate accountability of internal and external partners to provide information required to complete projects
  • Remain flexible and multitask well
  • Establish project priority and communicate timelines with external partners
  • Knowledge with ICP/MS and familiar with GC/MS, LC/MS, ICP-MS, and FTIR
  • Knowledge of Analytical method development and method qualification
  • External lab Data Review/Data Approval
  • Protocol and Report Writing, Review and Approval
  • Knowledge of lab work adhering to good laboratory practices (GLP), and Good Manufacturing Practices (GMP)
  • Become familiar with outside testing partners request process, PO and project schedule to submit samples and projects
  • Familiar knowledge of how to document, report, and review data in electronic lab notebook system
  • Knowledge of lab safety requirements

Basic Qualifications:

  • BA or BS in chemistry with 8 years of experience/MS with 4 years of experience/PhD with 2 years of experience
  • Expert in Extractable and Leachable analysis
  • Strong Knowledge of ISO 10993 Part 18
  • Ability to perform standard mathematic/statistical calculations in Microsoft Excel
  • Strong verbal and written communication skills
  • Ability to communicate  and collaborate effectively with chemistry team and management
  • Knowledge and application of GDP, GLP, and GMP
  • Ability to work autonomously with little oversight of day to day work
  • Knowledge and application of Microsoft suite of applications
  • Troubleshooting experience with systems referred to in primary responsibilities section
  • Method development and method validation experience
  • DOE/statistical analysis as applied to problem solving
  • Medical device background 

Desired/Preferred Qualifications:

  • Experience executing leachable experiments for elemental analysis.
  • Knowledge and utilization of Thermo ICP/MS or related ICP/MS equipment.
  • Experience managing projects with external contract research labs.
  • Available to travel to the CRO’s and initiate testing to maximize project success.

Working Conditions:

  • Working in lab environment with proper safety equipment. 
  • Working with common laboratory chemicals and biological tissue.
  • Working while sitting and /or standing. 

Physical Demands: Sitting, standing, lifting, carrying, etc.