Principal Engineer, Medical Device Dev & Packaging C&Q

Comunidade Metodista; New Albany (OH); On-site; USD 146,136,000 - 160,463,000; Part time

Job summary

3 Key Consulting is seeking an Engineer Principal for Medical Device Development & Packaging C&Q in New Albany, OH. This contract role focuses on leading teams in the development of drug delivery devices, including needle protection systems and automatic pen injectors.

Onsite work, standard hours, some after-hours for setup. The ideal candidate has 10 years of experience in engineering for medical devices and strong expertise in design, development, verification, validation, and regulatory

Qualifications

• 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.
• BS in Engineering and previous experience in a medical device industry.
• 10 years current experience with engineering processes and procedures.
• Led projects through 510(k) and PMA approval processes.
• Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC.
• Product design/development (design control) for Europe and US submissions.
• Familiar with 21 CFR 820, ISO 14971, EU directives, EN 60601.
• Small scale device assembly experience.

Responsibilities

• Work cross-functionally with Marketing, Operations, and Development.
• Create and assess product requirements to determine technical coverage across subsystems.
• Develop and manage project plans and schedules.
• Prepare architecture, design, specifications, development plans, validation plans, and other product development documents.
• Provide technical guidance for junior engineers.

Skills

Material & test specs

DOE/SPC process optimization

Design verification

Regulatory submissions

Cross-functional teamwork

Medical device development

Education

Doctorate in Engineering

Master's in Engineering

Bachelor's in Engineering

Associate degree with extensive experience

Tools

FMEA

IQ/OQ/PQ

Design control

Job description

3 Key Consulting is seeking an Engineer Principal for Medical Device Development & Packaging C&Q in New Albany, OH. This contract role focuses on leading teams in the development of drug delivery devices, including needle protection systems and automatic pen injectors.

Onsite work, standard hours, some after-hours for setup. The ideal candidate has 10 years of experience in engineering for medical devices and strong expertise in design, development, verification, validation, and regulatory