Medical Device Platform Design Engineer

Pharma Technical Operations (PT) is seeking a Medical Device Platform Design Engineer to contribute to the design and maintenance of Autoinjector and PFS-Needle Safety Device platforms. The role involves providing mechanical engineering expertise throughout the combination product lifecycle, from concept generation to sustaining engineering.

Responsibilities

• Act as a technical product design expert for platform-based combination products.
• Provide mechanical engineering design expertise and interface with external suppliers to oversee component and subassembly design.
• Lead reliability engineering assessments, including edge-of-failure testing, tolerance sensitivity, and digital twin modeling.
• Solve functional and assembly-related technical challenges and lead investigations into design, manufacturing, and scale-up issues.
• Manage product requirements, design reviews, risk assessments, and root cause investigations.

Requirements

• BS in Mechanical Engineering or equivalent with experience in prefilled syringes, autoinjectors, or novel drug delivery design.
• Familiarity with materials science, damage mechanisms, and performance testing in drug delivery systems.
• Proficiency in system modeling tools (CAE, FEA, MiniTab) and 3D CAD software like SolidWorks.
• Proven track record of technical leadership in a regulated environment.
• Strong communication skills and an entrepreneurial, hands-on approach to problem-solving.