Principal Engineer – Drug Delivery Device Development (Electro-Mechanical Combination Products) - (JP15480)

3 Key Consulting•New Albany, OH

2d•Onsite

About The Position

3 Key Consulting is hiring a Principal Engineer – Drug Delivery Device Development (Electro-Mechanical Combination Products) for a consulting engagement with our direct client, a leading global biopharmaceutical company. The qualified candidate will lead technical teams to ensure successful device development of mechanical and electro-mechanical medical devices. They 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.

Requirements

BS in Engineering and previous experience in a medical device industry.
Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience
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.
Strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background.

Nice To Haves

packaging process experience

Responsibilities

Lead teams in the development of drug delivery devices.
Lead technical teams to ensure successful device development of mechanical and electro-mechanical medical devices.
Develop detailed engineering specifications, device design & development.
Support verification, validation, and regulatory submissions of these devices.
Utilize technologies and methodologies that support short-cycle robust device development.
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.
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.