Associate Principal Scientist/Engineer, Medical Device and Combination Products, Analytical

About the role

The Center for Packaging & Device Analytics (CPDA) within our Manufacturing Division is seeking an Associate Principal Scientist/Engineer to lead analytical efforts for medical device or combination product development verification, method development, and testing.

Responsibilities

• Develop and own analytical strategies to satisfy Design Controls inputs.
• Manage analytical efforts to meet project timelines and deliverables.
• Lead cross-functional working groups to solve technical challenges related to mechanical devices.
• Collaborate with various engineering groups and partner analytical groups to ensure project success.
• Develop innovative Device Characterization and Design Verification (DV) strategies/mechanical tests with validations.
• Coordinate and oversee internal CPDA staff or external lab testing to meet project timelines and deliverables.

Requirements

• Ph.D. in Mechanical, Chemical, or Biomedical Engineering (or equivalent field).
• A minimum of 3 years of experience in a role responsible for medical device or combination product development verification, method development, and testing.
• Experience with mechanical testing, imaging, and measurement equipment and techniques, including tensile/compression/torsional testing, materials characterization, x-ray computed tomography, rheometry, and microscopy.
• Excellent collaboration and leadership skills to work as part of cross-functional teams.

Preferred Skills

• Experience developing innovative Device Characterization and Design Verification (DV) strategies/mechanical tests with validations, including engineering studies, design verification protocols, stability studies, and validation protocols.
• Understanding/familiarity of Design Controls (21 CFR 820.30) and relevant industry standards.
• Experience with medical device development.

Skills

• Analytical Chemistry.
• Computed Tomography (CT).
• Cross-Cultural Awareness.
• Design Validations.
• Device Characterization.
• Interdisciplinary Collaboration.
• Materials Characterization.
• Mechanical Testing.
• Medical Devices Engineering.
• Microscopies.
• Professional Networking.
• Rheometry.
• Tensile Strength Testing.
• Tomography.
• X Ray Imaging.

Pay

$142,400.00 - $224,100.00

Schedule

Flexible work arrangements are not applicable.