Principal Design Engineer

Overview

Our client is seeking a Principal Design Engineer to serve as the technical lead for injector and drug delivery device development programs. This individual will provide hands-on engineering leadership across product development activities, supplier engagement, risk management, testing, and commercialization efforts while partnering closely with cross-functional teams to advance combination products.

This role is onsite 5 days/week

Responsibilities

• Lead injector and medical device development projects from concept through commercialization
• Provide technical leadership for design, testing, risk management, and product lifecycle activities
• Drive mechanical design evaluations, tolerance analysis, testing strategies, and manufacturing readiness
• Partner with suppliers, contract manufacturers, and development partners to support device development and issue resolution
• Lead risk management activities including FMEA, hazard analysis, and mitigation planning
• Support design controls, DHF documentation, verification/validation, and regulatory submissions
• Collaborate with Quality, Regulatory, Manufacturing, Clinical, and Human Factors teams to ensure successful product development and compliance
• Mentor engineers and contribute to technical strategy and decision-making

Qualifications

• BS or MS in Mechanical Engineering, Biomedical Engineering, or related discipline
• 10+ years of medical device product development experience
• Demonstrated experience leading injector, drug delivery, or combination product development programs
• Strong proficiency with SolidWorks and mechanical design principles
• Hands-on experience with mechanical testing, tolerance analysis, injection molding, packaging development, cleaning/process validation activities, and risk management (FMEA, Hazard Analysis)
• Experience working with suppliers, CMOs, and external development partners
• Strong verbal communication skills with the ability to lead technical discussions across internal and external stakeholders
• Experience supporting products through design controls, verification/validation, and commercialization

Preferred Qualifications

• Combination product experience within pharmaceutical or biotechnology environments
• Ophthalmic, injectable, or drug delivery device experience
• Experience with DHF remediation and compliance with 21 CFR Part 4, 21 CFR 820, ISO 13485, and ISO 14971
• Project leadership experience managing timelines, deliverables, and cross-functional teams