Product Process Engineer

Top Skills & Experience Required:

• Hands-on lab experience in product development & manufacturing of medical devices, drug-device delivery systems, or combination products.

• Strong background in DOE, product functionality testing, reliability, and characterization.

• Experience in product investigations, compliance, data analysis, technical reports & presentations.

• Product/process design, verification, validation, and commercial scale-up knowledge.

• Excellent communication, technical writing, and ability to work independently.

Education/Experience:

• BS (5 yrs exp.); MS (3 yrs exp.); PhD acceptable (2 yrs exp.).

• Fields: Biomedical, Mechanical, Chemical, Materials Science, Biotechnology, or related Engineering.

Nice to Have:

• Knowledge of FDA/ISO standards, cGMP, design history file, tech transfer, and CMOs.

• Experience with pre-filled syringes, auto-injectors, eye care devices, or pump systems.

• Strong skills in documentation (SOPs, validation protocols), electronic notebooks, and cross-functional teamwork.

Responsibilities:

• Support development, scale-up, and manufacturing of drug-device systems & combination products.

• Conduct lab studies, DOE experiments, and product testing for accuracy, sensitivity & reliability.

• Prepare technical documentation, reports, and presentations.

• Collaborate with cross-functional teams (R&D, Quality, Regulatory, Manufacturing, CMOs).

• Ensure compliance with FDA/ISO standards and troubleshoot manufacturing challenges.