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

Role: Associate Principal Scientist/Engineer leading analytical development for medical device and combination product (MDCP) projects within packaging and device analytics.

Responsibilities

• develop and own analytical strategies for device characterization and design verification, including mechanical testing, imaging, and validation; oversee internal and external testing efforts; collaborate cross-functionally to meet project timelines.

Requirements

• Ph.D. in Mechanical, Chemical, Biomedical Engineering or equivalent; minimum 3 years’ experience in medical device or MDCP verification, method development, and testing; proficiency with mechanical testing, imaging (X-ray CT, microscopy), and materials characterization; strong collaboration and leadership skills.

Preferred

• experience creating innovative device characterization/verification strategies, familiarity with Design Controls (21 CFR 820.30), and industry standards.

High-Value

• focus on medical devices such as auto-injectors, pre-filled syringes; development and validation of mechanical test methods; leadership in interdisciplinary teams; located at West Point, PA with 10% travel.

Work setup

• onsite, regular hours.