Principal Engineer (Delta V Automation) Location: Onsite (Building 30), 5 days per week, regular business hours (8:30 AM - 5:30 PM) NO RELOCATION Duration: 3-year contract On-call requirement: Minimal (rotational approximately every 7 weeks; typically 1-hour calls weekly) The ideal candidate for the Principal Automation Engineer (Delta V) role will have extensive expertise in Delta V batch control systems, with a minimum of 4-5 years of direct, hands-on Delta V experience specifically in pharmaceutical manufacturing environments. They should demonstrate proficiency in coding, troubleshooting, and addressing complex alarms or system issues in Delta V. Candidates should ideally hold a Bachelor's degree (Chemical, Electrical, Automation Engineering, Computer Science, Electronics, or similar technical field). However, substantial practical Delta V experience can outweigh formal educational qualifications. A strategic mindset, excellent troubleshooting skills, and strong interpersonal capabilities are crucial, as the role involves frequent collaboration across various teams. Experience in PLC systems and Delta V system administration is beneficial but not mandatory. Candidates must show a track record of stability in their previous employment, with demonstrated capacity for maintaining long-term roles. 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, and 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 Principle 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 Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Responsibilities: - 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. Skills: - BS in Engineering and previous experience in a medical device 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. VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!