Sr Device Engineer I

职位描述

We are seeking a highly skilled and proactive Senior Device Development Engineer to lead technical development efforts for parenteral drug-device combination products, including autoinjectors, prefilled syringes, and needle safety systems. This individual contributor role is ideal for an engineer with deep technical expertise, strong cross-functional collaboration skills, and a passion for delivering innovative, patient-centric solutions. The role may include oversight of contractors or matrixed resources but does not include direct people management.

Key Responsibilities:

• Lead technical development activities for combination products from concept through commercialization, ensuring robust design and performance.
• Develop and execute design control documentation, including design inputs/outputs, verification, validation, and risk management.
• Author and review technical reports and contribute to regulatory submissions (IND, NDA, etc.).
• Collaborate cross-functionally with Regulatory, Quality, Clinical, and Manufacturing teams to align on development strategy and execution.
• Support technology transfer to clinical and commercial manufacturing sites, including process development and troubleshooting.
• Drive technical problem-solving, root cause analysis, and continuous improvement initiatives.
• Represent the device development function in internal and external technical discussions, including with suppliers and partners.
• Stay current with industry standards and regulatory expectations, including FDA, EMA, ISO 13485, ISO 14971, and cGMP.

Basic Qualifications:

• Doctorate OR
• Master’s and 4+ years of relevant experience OR
• Bachelor’s and 6+ years of relevant experience OR

Preferred Qualifications:

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field.
• Minimum of 6+ years (BS) or 4+ years (MS) of relevant experience in combination product development.
• Strong understanding of design control, risk management, and regulatory standards for combination products.
• Demonstrated ability to solve complex technical problems and contribute to strategic project decisions.
• Excellent communication and collaboration skills; able to work effectively across functions and with external partners.