npi engineer lead

Randstad • Saint Petersburg, FL

427d • $118,560 - $151,840

About The Position

The NPI Engineer Lead will play a crucial role in launching innovative medical devices by collaborating with cross-functional teams throughout the product development process. This position involves leading technical efforts, mentoring engineers, and ensuring compliance with regulatory standards while overseeing risk management, prototyping, testing, and process optimization.

Requirements

• Minimum 5 years of experience in NPI and medical devices.
• Bachelor's degree in a relevant field.
• Professional Engineer certification.

Nice To Haves

• Experience with medical catheters, adhesive dispensing, laser welding, and UV bonding.
• Strong project management skills.
• Knowledge of plastics and CAD.

Responsibilities

• Lead technical aspects of product launch, ensuring milestones align with scope, schedule, and budget.
• Mentor and guide engineers, fostering innovation and best practices.
• Collaborate with R&D, regulatory, quality, supply chain, and manufacturing teams.
• Oversee design, prototyping, testing, and manufacturing of new medical devices.
• Identify risks early, conduct FMEA, and implement mitigation plans.
• Ensure compliance with regulatory standards (FDA, ISO 13485, CE).
• Support regulatory submissions, audits, and validation processes (IQ, OQ, PQ).
• Develop and review technical documentation (DHF, risk files, validation reports).
• Promote continuous improvement and process optimization in engineering practices.
• Utilize CAD tools, understand manufacturing processes, and DFx principles.
• Communicate technical concepts effectively to diverse stakeholders.
• Travel up to 50% for on-site product launch activities.

Benefits

• Comprehensive health benefits
• Incentive and recognition program
• 401K contribution

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree