Engineer Principal

ACL Digital • New Albany, OH

75d

About The Position

The Principal Engineer will lead teams in the development of drug delivery devices, which include a wide range of products such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will work closely with team members to develop detailed engineering specifications, device design and development, and support verification, validation, and regulatory submissions of these devices. This role requires collaboration within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Requirements

• BS in Engineering and previous experience in the 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

Nice To Haves

• Strong Electrical Engineering background
• Strong Mechanical Engineering background

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 of different subsystems
• Create and execute project plans and schedules
• Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plans, verification and validation plans, and other related product development documents for assigned projects
• Provide deep technical assistance for junior engineers

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees