Process Development Engineer

We are seeking a skilled Process Development Engineer with experience in the Medical Device or Pharmaceutical industry to support the development, optimization, and validation of manufacturing processes for drug/device combination products. This role is ideal for candidates with strong expertise in packaging, assembly processes, and working within regulated environments. Position Summary You will play a key role in driving process development activities from concept through commercialization. The position requires hands‑on involvement in process characterization, validation, and continuous improvement while ensuring compliance with FDA and quality standards. Key Responsibilities Develop, optimize, and validate manufacturing processes for medical devices, pharmaceutical products, and combination products Lead process development activities for packaging and assembly operations Design and execute DOE (Design of Experiments) for process characterization and optimization Perform risk assessments using FMEA methodologies Develop and implement SPC strategies for process monitoring and control Author and execute IQ, OQ, PQ validation protocols and reports Support design verification and validation activities Apply Design Control principles throughout the product lifecycle Create technical documentation including protocols, reports, and work instructions Collaborate with cross‑functional teams such as R&D, Quality, Manufacturing, Regulatory, and Supply Chain Build and evaluate prototypes to support development activities Troubleshoot manufacturing issues and drive CAPA activities Ensure compliance with FDA regulations, GMP, ISO 13485, and quality standards Required Qualifications Bachelor’s degree in Mechanical, Biomedical, Chemical, or Manufacturing Engineering 3+ years of experience in process development within Medical Device or Pharma industry Strong experience in packaging and assembly processes Hands‑on experience with FMEA, DOE, SPC, Design Controls, and IQ/OQ/PQ validation Experience with Verification and Validation (V&V) Strong documentation and technical writing skills Knowledge of FDA regulations, GMP, and ISO 13485 Strong analytical and problem‑solving skills Preferred Qualifications Experience with drug/device combination products Experience supporting New Product Development (NPD) Knowledge of Lean Manufacturing and Six Sigma methodologies Familiarity with CAPA, change control, and risk management processes Experience working in regulated manufacturing environments #J-18808-Ljbffr