Principal Medical Device Engineer (Design Control/CFR)

Infotree Global Solutions; New Albany (OH); On-site; USD 100,000 - 130,000; Full time

Job summary

Infotree Global Solutions in New Albany, Ohio, is seeking a Principle Engineer to lead the development of drug delivery devices. This role involves collaboration with cross-functional teams in Marketing, Operations, and Development to create detailed engineering specifications and support regulatory submissions.

The ideal candidate has a BS in Engineering and over 10 years of medical device experience, focusing on electro-mechanical design and risk management, and can handle multiple projects effectively.

Qualifications

• 10+ years of experience in a medical device industry.
• Experience with 510(k) and PMA approval process.
• Strong problem-solving skills.

Responsibilities

• Work cross-functionally with project teams.
• Create and assess product requirements.
• Develop and review engineering specifications.

Skills

Engineering processes and procedures

DOE/SPC process optimization

Electro-mechanical device design

Prototyping

Risk assessment

Material & test specifications

Education

BS in Engineering

Job description

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.

Job Summary

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.

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.

Qualifications

• 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 (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.

Must-Have Skills

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

Day-to-Day Responsibilities

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.

Important Note

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