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Job #02847

About our client Our client is a globally recognized medical device company headquartered in Ohio for over 100 years. They specialize in manufacturing devices for patients that are easy to use and affordable. They have many products on sale on the market today! They boast a 58 square-foot state-of-the-art manufacturing facility, an experienced management team and an excellent development program. This is a great opportunity for the successful candidate! Position Location Product Development Chemist Cleveland, Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop and update test methods for analysis of new and existing products (designing instrumentation, writing SOPs and transferring methodology as required) 2) Generate and document all activities (to the level necessary) to comply with cGMPs and ISO requirements 3) Design and execute feasibility studies for new and improved products, packaging and product analytical testing as well as manufacturing processes 4) Generate documents required under design controls 5) Act as a Study Director for completion of GLP studies (new and improved products) 6) Work as a Study Director to develop testing protocols, provide support and resources to analysts and create final reports, summarizing the results of tests 7) Coordinate with acquisition, procurement, fabrication, etc. when new raw materials/components are required to transition new products through development, validation and sales 8) Interact with Engineering, RA and the QA Departments to develop the requirements for new and improved products, packaging, analytical testing and manufacturing processes 9) Interact with outside vendors and suppliers to develop and/or procure components for prototypes and pilot batches 10) Perform literature reviews and research activities to gain expertise and insight into new and existing technologies that are applicable to the company 11) Utilize recognized statistical methods and approaches to qualify new products 12) Maintain an ‘Engineer for Safety’ and ‘Risk Analysis’ attitude toward all products, component and equipment designs, and process implementations 13) Investigate customer complaints and CAPA reports with the QA Department 14) Document failure analysis and write final reports (as required) 15) Assist with the setup of training programs in compliance with OSHA 16) Handle administration of (OSHA) fire safety, hazardous materials, safety training, etc. 17) Participate in proactive team efforts to achieve departmental and company goals 18) Comply with all company policies, practices and procedures 19) Assist with internal and external audits Requirements 1) B. Sc. in Chemistry/Biology/Physics or Engineering 2) 3 – 5 years of experience in the medical device or pharmaceutical industry 3) Knowledge of cGMP and GLP requirements 4) Familiarity with aerosol gas handling, aerosol filling, blending, transferring and delivery 5) Experience in packaging and labeling equipment required for medical devices a plus 6) Expertise in installation qualifications, operational qualifications and process qualifications an asset 7) Working knowledge of product compatibility testing methods for aerosols a plus 8) Expertise in statistical analyses methods and techniques 9) Ability to handle multiple projects simultaneously 10) Highly organized, accurate and detail-oriented 11) Ability to develop analytical test methods in support of design transfer 12) Proficiency in MS Office and personal computer skills 13) Excellent communication skills (verbal and written)