Associate Principal Scientist/Engineer, Medical Device and Combination Products, ISO/DV Testing Manager
Job in
Bensalem, Bucks County, Pennsylvania, 19020, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Engineering
Regulatory Compliance Specialist, Quality Engineering, Biomedical Engineer
Job Description & How to Apply Below
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
- coach laboratory analysts
- 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
- mechanical testing expertise
- management experience
- familiarity with medical device development, Design Controls (21 CFR 820.30), ISO 13485, cGMP
- hands-on experience in device characterization, design verification, and analytical strategy
- focus on MDCPs such as auto-injectors and pre-filled syringes
- mechanical/dimension testing
- container integrity
- related analytical methods
Collaboration with internal teams and external labs.
LocationWest Point, PA; travel ~10%.
Qualifications highlight biopharma device development, regulatory standards, and laboratory operations.
Position Requirements
10+ Years
work experience
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