Senior Engineer II, Project

About the role

The Senior Project Engineer II plays a crucial role in coordinating with various departments to manage capital projects, manufacturing support, and continuous improvements. They are responsible for investigating, determining root cause, and implementing corrective and preventive actions for manufacturing quality issues. Additionally, they lead the implementation of changes within Integra's change management program, manage capital projects, and ensure the successful transfer of new products to production.

Responsibilities

• Develop, improve, and maintain the project management system
• Manage project management for capital projects, continuous improvement projects, design transfer projects, and system projects (SCADA, AI, CMMS, ect...)
• Lead continuous improvement changes by implementing measures to improve production methods, equipment performance, and quality of product
• Evaluate, implement, and monitor equipment for the manufacture of medical products
• Author, review, and execute IQ, OQ, and PQ protocols
• Utilize Process Failure Mode and Effects Analysis (PFMEA) and Design Of Experiments to analyze manufacturing processes
• Test protocol generation, execution, and reporting
• Contribute to department strategy and budget planning
• Participate in design reviews with the product development teams
• Interface with procurement to identify and evaluate new and replacement raw materials
• Mentor junior engineers on cGMPs and good engineering practices, including review of technical documentation
• Ensure proper documentation is completed to meet quality system requirements
• Aid in the preparation and completion of cost estimates, reports, forecasts, schedules, and budgets
• Interface with others in the organization to ensure deadlines, quality requirements, and production metrics are met

Qualifications

• Bachelor’s degree in Electrical Engineering, Mechanical Engineering, or related engineering discipline
• Minimum of 5 – 7 years of industry experience in engineering; medical device industry experience is a plus
• Significant leadership and mentoring experience is required
• Experience managing, leading and implementing significant cross-functional projects
• Experienced in transferring and launching new products in manufacturing, medical device experience in design control is a plus
• Leverage Lean Six Sigma Experience
• Computer proficiency required

Skills

• Ability to manage multiple projects simultaneously, including task delegation
• Excellent analytical thinking and technical writing skills
• Communicates effectively with management and peers
• Demonstrates ability to plan & schedule work in order to deliver on both small and large project timelines (multi-year timelines, multi-department resourcing)
• Demonstrates competence in performing/leading root cause investigations
• Demonstrates competence in initiating & leading manufacturing changes through change control
• Demonstrates comprehensive understanding of the elements of design control
• Demonstrates ability to author, review, and approve technical and controlled documents for engineering, such as study reports and SOPs
• Demonstrates competence in all applicable engineering disciplines
• Demonstrates ability and initiative to mentor Associate / Staff engineers
• Proficiency in statistical analysis such as tolerance interval analysis, capability analysis, hypothesis tests and design of experiments
• Project Management skills including critical path identification, delegation, risk management, stakeholder management, and effective communication are required

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Pay

$94,300.00 - $129,950.00 USD Salary

Schedule

5% - 10% travel required