Process Development Engineer

Role: Process Development EngineerLocation: Ohio (Onsite)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 SummaryYou 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 ResponsibilitiesDevelop, optimize, and validate manufacturing processes for medical devices, pharmaceutical products, and combination productsLead process development activities for packaging and assembly operationsDesign and execute DOE (Design of Experiments) for process characterization and optimizationPerform risk assessments using FMEA methodologiesDevelop and implement SPC strategies for process monitoring and controlAuthor and execute IQ, OQ, PQ validation protocols and reportsSupport design verification and validation activitiesApply Design Control principles throughout the product lifecycleCreate technical documentation including protocols, reports, and work instructionsCollaborate with cross-functional teams such as R&D, Quality, Manufacturing, Regulatory, and Supply ChainBuild and evaluate prototypes to support development activitiesTroubleshoot manufacturing issues and drive CAPA activitiesEnsure compliance with FDA regulations, GMP, ISO 13485, and quality standardsRequired QualificationsBachelor’s degree in Mechanical, Biomedical, Chemical, or Manufacturing Engineering3+ years of experience in process development within Medical Device or Pharma industryStrong experience in packaging and assembly processesHands-on experience with FMEA, DOE, SPC, Design Controls, and IQ/OQ/PQ validationExperience with Verification and Validation (V&V)Strong documentation and technical writing skillsKnowledge of FDA regulations, GMP, and ISO 13485Strong analytical and problem-solving skillsPreferred QualificationsExperience with drug/device combination productsExperience supporting New Product Development (NPD)Knowledge of Lean Manufacturing and Six Sigma methodologiesFamiliarity with CAPA, change control, and risk management processesExperience working in regulated manufacturing environments