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

Role: Associate Principal Scientist/Engineer overseeing analytical method validation and transfer for medical device/combination products (MDCPs), focusing on design verification testing in ISO labs and external partners. Responsibilities: manage and execute MDCP testing to support commercial timelines, provide technical oversight of analytical methods, ensure cGMP and ISO 13485 compliance, drive development of new testing technologies, and coach laboratory analysts. Requirements: BS, MS, or PhD in Mechanical, Chemical, or Biomedical Engineering or related fields; 3+ years (PhD) or 6+ years (BS/MS) in industry analytical testing within cGMP/ISO environments; strong knowledge of regulatory compliance and quality assurance. Preferred: mechanical testing expertise, management experience, familiarity with medical device development, Design Controls (21 CFR 820.30), ISO 13485, cGMP, and hands-on experience in device characterization, design verification, and analytical strategy. High-Value: focus on MDCPs such as auto-injectors and pre-filled syringes, mechanical/dimension testing, container integrity, and related analytical methods. Collaboration with internal teams and external labs. Location: West Point, PA; travel ~10%. Qualifications highlight biopharma device development, regulatory standards, and laboratory operations.