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

About the role

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.

Responsibilities

• Lead teams in the development of drug delivery devices, including needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
• Work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
• 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.

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

Qualifications

• 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.

Skills

• 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

Benefits

Standard 8-5 work schedule with onsite AOH (Monday - Friday).

Pay

$52 - $57/hour W2

Schedule

Standard 8-5 work schedule with onsite AOH (Monday - Friday).