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

Scorpion Therapeutics; Pennsylvania; On-site; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Principal Scientist/Engineer to oversee analytical method validation and transfer for MDCPs, focusing on design verification testing in ISO labs and with external partners.

You will lead MDCP testing programs, ensure cGMP/ISO 13485 compliance, and guide analysts while collaborating with internal and external labs. West Point, PA with travel ~10%.

Qualifications

• Degrees in mechanical/chemical/biomedical engineering or related fields.
• 3+ years (PhD) or 6+ years (BS/MS) in industry analytical testing within cGMP/ISO environments.
• Experience with regulatory compliance and quality assurance in medical device contexts.

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.

Skills

Analytical testing

cGMP compliance

ISO 13485

Regulatory compliance

Design verification

Team coaching

Mechanical testing

Laboratory oversight

Education

BS/MS/PhD in Mechanical, Chemical, or Biomedical Engineering

Job description

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
• 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
• 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
• related analytical methods

Collaboration

Collaboration with internal teams and external labs.

Location

West Point, PA; travel ~10%.

Qualifications highlight biopharma device development, regulatory standards, and laboratory operations.