Device Engineer II

Scorpion Therapeutics; West Chester (Chester County); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Paid time off

Life insurance

Disability insurance

Job summary

Scorpion Therapeutics seeks a Device Engineer II for Combination Product Development. You will develop 3D CAD models, assemblies, drawings, and testing fixtures (SolidWorks or equivalent) to support device development, characterization, verification testing, and manufacturing.

Responsibilities include testing of drug delivery devices, documenting results per GDP, evaluating components, and collaborating with QA, Regulatory, and Manufacturing while applying ISO 13485, ISO 14971, and 21 CFR Part

Qualifications

• BS in Mechanical Engineering, Biomedical Engineering, or related field.
• 0–2 years experience in pharmaceutical, biotech, or medical device.
• Strong foundation in solid mechanics, mechanical design, and fluid dynamics; interest in medical device/drug delivery systems.
• Hands-on lab experience with physical testing or mechanical systems.
• Ability to follow protocols and SOPs; effective written/verbal communication.
• Eagerness to learn in a collaborative, regulated environment.
• Ability to manage concurrent technical activities and prioritize workload while maintaining quality/compliance.

Responsibilities

• Develop detailed CAD models, assemblies, and drawings for device development.
• Perform physical testing of drug delivery devices using lab equipment.
• Set up, execute, and document testing activities per GDP.
• Support development, verification, and validation of test methods.
• Evaluate device components for fit, function, and quality.
• Participate in basic root cause investigations of deviations.
• Contribute to technical reports, data summaries, and design verification/regulatory submissions.
• Collaborate with QA, Regulatory, and Manufacturing; learn ISO standards.

Skills

Solid mechanics

Mechanical design

Fluid dynamics

Written/verbal comms

Lab experience

SOPs adherence

Education

BS in Mechanical Eng or Biomedical Eng

Tools

SolidWorks

Job description

Device Engineer II (Combination Product Development)

Responsibilities

• Develop detailed 3D CAD models, assemblies, engineering drawings, and testing fixtures (SolidWorks or equivalent) for device development, characterization, verification testing, and manufacturing support.
• Perform physical testing of drug delivery devices (e.g., injection force, injection time, dose accuracy) using lab equipment such as Instron or Zwick.
• Set up, execute, and document testing activities per protocols and Good Documentation Practices (GDP).
• Support development, verification, and validation of test methods under senior engineer guidance.
• Assist in evaluation of device components (e.g., stoppers, barrels, springs) for fit, function, and quality.
• Participate in basic root cause investigations of product/test method deviations.
• Contribute to technical reports, data summaries, and design verification/regulatory submission documentation.
• Collaborate with QA, Regulatory, and Manufacturing.
• Learn and apply quality/regulatory standards (ISO 13485, ISO 14971, 21 CFR Part 820).

Qualifications/Skills

• BS in Mechanical Engineering, Biomedical Engineering, or related field.
• 0–2 years experience in pharmaceutical, biotech, or medical device.
• Strong foundation in solid mechanics, mechanical design, and fluid dynamics; interest in medical device/drug delivery systems.
• Some hands‑on lab experience (academic, co‑op, or internship) with physical testing or mechanical systems.
• Ability to follow protocols/SOPs; effective written/verbal communication.
• Eagerness to learn in a collaborative, regulated environment.
• Ability to manage concurrent technical activities and prioritize workload while maintaining quality/compliance.

Benefits (explicitly listed)

• Comprehensive health insurance; 401(k) match/defined contribution; Paid Time Off; company-paid life and disability insurance.