Principal Medical Device Engineer; Design Control​/CFR

Very occasional need to have candidates work later into the day due to occasional set up that may be needed. Approximately 1-2x per month. International travel may be required for this position.

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 Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, and support verification, validation, and regulatory submissions of these devices.

The role is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

• 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.

• BS in Engineering and 10+ years of experience in a medical device industry.
• Experience with engineering processes and procedures, and led projects from development through the 510(k) and PMA approval process.
• Strong background in engineering and commercialization of electro-mechanical medical devices.
• Experience with material & test specifications 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) and U.S. (FDA/PMA/510(k) submissions).
• Experience in drug/device combination product design and development.
• Familiar with Quality System Regulation (21
  
  CFR
  820), 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.

• DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
• Packaging process experience is a plus.

Position involves support of Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third-party firms.

Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!