Associate Principal Scientist/Engineer, Medical Device and Combination Products, ISO/DV Testing Manager

Responsibilities

• Strategic and tactical (day-to-day) management of design verification testing to support our commercial products to meet critical project timelines.
• Techical oversight of method development, validation, and implementation of analytical methods and associated investigational support at both internal and external laboratories.
• Ensuring safety, environmental and cGMP and ISO 13485 compliance for all laboratory activities and operations.
• Collaborating with CPDA program leads to drive test method development, validation and implementation of new instrumentation/analytical technologies for the laboratory to support current and future commercial MDCP DV testing.
• Oversight and technical coaching of CPDA analysts in the ISO laboratory.

Requirements

• BS, MS or PhD in Mechanical, Chemical or Biomedical Engineering or associated scientific discipline, such as Chemistry.
• A minimum of 3 years with PhD, or 6 years with BS or MS, in an industry role centered on analytical testing.
• Successful work within a cGMP or ISO 13485 certified analytical laboratory.
• Demonstrated competency with mechanical testing.

Preferred Experience & Skills

• Successful manager / supervisor of staff within a cGMP or ISO 13485 certified analytical laboratory.
• Expertise with medical device development and understanding/familiarity of Design Controls (21 CFR 820.30), ISO 13485, cGMP, and relevant industry standards.
• Hands-on experience in MDCP method development, Device Characterization, and Design Verification (DV) for development, engineering studies, design verification, stability studies and/or validation—including analytical strategy and protocol design.
• Advanced expertise with mechanical functionality and strength testing, container closure integrity testing and dimensioning—such as (not limited to) tensile/compression/torsional testing, optical or x-ray microscopy, optical comparator methods, dye ingress testing, etc.

Skills

• Analytical Development
• Analytical Testing
• GMP Laboratory
• GMP Testing
• Interdisciplinary Collaboration
• Mechanical Testing
• Medical Device Management
• Medical Devices
• Medical Device Technologies
• Medical Device Testing
• Synthetic Chemistry
• Test Procedure Development

Qualifications

• BS, MS or PhD in Mechanical, Chemical or Biomedical Engineering or associated scientific discipline, such as Chemistry.
• A minimum of 3 years with PhD, or 6 years with BS or MS, in an industry role centered on analytical testing.
• Successful work within a cGMP or ISO 13485 certified analytical laboratory.
• Demonstrated competency with mechanical testing.