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

What you'll do

• Manage and oversee design verification testing activities for medical device combination products.
• Provide technical oversight for the development, validation, and implementation of analytical methods at internal and external laboratories.
• Ensure all laboratory operations comply with safety, environmental, cGMP, and ISO 13485 standards.
• Drive the development of new instrumentation and analytical technologies to support current and future product testing.
• Provide technical coaching and leadership to analysts within the designated laboratory environment.
• Execute mechanical testing including tensile/compression/torsional testing and container closure integrity testing.
• Develop test methods, validation protocols, and investigation support for drug-delivery medical devices.

What we're looking for

• BS, MS, or PhD in Mechanical, Chemical, Biomedical Engineering, or a related scientific discipline like Chemistry.
• Minimum of 3 years experience with a PhD, or 6 years with a BS or MS, in an industry role centered on analytical testing.
• Experience working within a cGMP or ISO 13485 certified analytical laboratory.
• Strong knowledge and experience with regulatory compliance principles including GMPs, GDPs, and quality assurance practices for analytical testing.
• Demonstrated competency with mechanical testing (preferred).
• Experience as a manager or supervisor of staff within a cGMP or ISO 13485 certified analytical laboratory (preferred).
• Expertise in medical device development, Design Controls (21 CFR 820.30), and related industry standards (preferred).
• Hands-on experience in MDCP method development, Device Characterization, and Design Verification (preferred).