Engineer Senior, Combination Medical Devices (JP11927)

Lead teams in the development of drug delivery devices, including needle protection systems, fluid transfer devices, pen injectors, and micro-infuser delivery pump systems. 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.

Requirements

• Technical writing skills-experience in writing on owning GMP documents and records
• Oversight and management of multiple projects and tasks for 3rd party suppliers
• Data analysis to develop insights and strategies
• Management of 3rd party supplier ensuring Quality Agreement is adhered to
• Tracking of key metrics and performance indicators
• 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 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
• Basic Qualifications: Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
• 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: Quality System Regulation - 21CFR820, Risk Management ISO 14971, EU Medical Device requirements, Council Directive 93/42/EEC, 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

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Retirement plan
• Paid time off