Engineer Senior, Drug Delivery Devices (JP11638)

Job Title: Engineer Senior, Drug Delivery Devices (JP11638) Location: Louisville, KY. 40201 Business Unit: Logistics and Transportation. Employment Type: Contract Duration: 1+ years (with possible extensions) Rate : $46 - $51hour W2 Posting Date: 06/01/2023 Notes: OnlyQualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered. 3 Key Consulting is recruiting an Engineer Senior, Drug Delivery Devices for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as: Needle protection systems Fluid transfer devices Pen injectors Automatic pen injectors Micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Senior Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Senior Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Responsibilities include: Work cross-functionally with individuals and project teams in Marketing, Operations, and Development Create and assess product requirements to determine technical coverage and proper integration different subsystems. Create and execute to project plans and schedules Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects. Provide deep technical assistance for junior engineers. Top Must Have Skill Sets: Systems/Software Engineering background Strong problem solving, risk assessment, and risk management skills. Create and execute to project plans and schedules Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!! Day to Day Responsibilities: Third Party Supplier management Inventory analysis and management Analytical reporting and data collection Basic Qualifications: BS in Engineering and previous experience in a medical device industry, supply chain and QA in a medical industry. 10 years current experience with engineering processes and procedures. Led projects from development through the 510k and PMA approval process. Strong background in engineering and commercialization of electro-mechanical medical devices. Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. - Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. Experience in drug/device combination product design and development Familiar with the following standards: o Quality System Regulation 21CFR820 o Risk Management ISO 14971 o EU Medical Device requirements Council Directive 93/42/EEC o Medical Electrical Equipment

EN 60601

Small scale device assembly experience. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Strong problem solving, risk assessment, and risk management skills. Must be capable of working on multiple projects in a deadline driven environment. Why is the Position Open? Supplement additional workload on team Red Flags: Excessive changes in employers over short span (1-2 years) Candidates that are too green to engineering. Needs more thaneducation background. Interview Process: Phone Interview followed by WebEx meeting/panel interview We invite qualified candidates to sendyour resume to View email address on click.appcast.io . Ifyou decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role. #J-18808-Ljbffr 3key Consulting, Inc.