The Design Support Engineer is responsible for the DHF, engineering drawing, and testing support for mechanical and electrical design changes of the products produced at the client’s Cincinnati site. Responsibilities will require a familiarity with multiple engineering disciplines (mechanical, electrical & manufacturing) and a thorough understanding of the site design control process and of statistical methods used to evaluate effectiveness of design changes.
Principal Duties & Responsibilities: 1. Manage the maintenance of DHF documentation for Cincinnati products to ensure regulatory compliance and conducts audits of technical files as required. 2. Lead and participate in the risk management process, including preparation of requirements generation, risk analysis and FMEA. 3. Partner and work with cross functional teams from other disciplines and potentially other business units. 4. Provide technical support for product changes and new product manufacturing requirements. Develop and implement project plans from concept through feasibility, development, qualification and launch. 5. Identify, evaluate and implement cost reduction opportunities for Cincinnati products. 6. Provide product and component specification drawings in support of the Cincinnati manufacturing operations. 7. Responsible to ensure that all product development and design changes conform to the requirements of the Cincinnati Design Control procedures. 8. Coordinates DHF and design change reviews as required by the design control process. 9. Develop, review and approve engineering change orders, ECO’s, considering improvements to quality, cost, customer requirements. 10. Develop, document and lead product and/or process pilot runs and validations for product changes. 11. Participate in regulatory audits, FDA, ISO, UL, ETL, MDD, IEC etc. and resolves findings. 12. Lead and/or support efforts for continuous improvements through the use Six Sigma methodology and/or Lean activities. 13. Analyze, implement, and document improvements to design control process. 14. Perform other duties that might be required as directed by the Product Engineering Manager.
Knowledge, Skills & Abilities Required: 1. Bachelors degree in Biomedical, Mechanical or Electrical Engineering 2. Proficient in the use of computer software applications to support the design process (i.e. AutoCad, Pro-E, Doors, PCAD, Agile). 3. Experience with the creation of protocols and application of testing methods and principles. 4. Familiarity with DOORs, Requisite Pro and Filemaker Pro. 5. Minimum of 2 years experience in the Medical Device field 6. Back ground in both medical device and medical disposable products. 7. Experience in medical device design preferred. 8. Strong interpersonal skills with ability to work with various business functions (Operations, Quality, Service, etc.) 9. Ability to effectively manage multiple projects simultaneously. Use of project management skills throughout the project concept, feasibility, development, qualification and launch. 10. Certification in Six Sigma (DFSS, DMAIC) and/or Lean manufacturing principles preferred. 11. Self-starter and capable of working with minimal supervision. 12. Strong written and verbal communication, organizational and facilitation skills.