Senior Engineer II, Project

Integra LifeSciences•Columbia, MD

15d•$94,300 - $129,950•Onsite

About The Position

The Senior Project Engineer II will coordinate with Production, Quality, Research & Development, and external suppliers to manage capital projects, manufacturing support, and continuous improvements under guidance of engineering leadership within the constraints of domestic and foreign Medical Device Regulations. The employee will investigate, determine root cause, and implement corrective and preventive actions for manufacturing quality issues. The engineer will initiate and lead the implementation activities for changes approved within Integra’s change management program. The engineer will also manage and drive capital projects including design, build, commissioning, and qualification, ensuring the proper goals and milestones are met on time and within budget. The project engineer will work within cross-functional core teams on the development of new products ensuring on-time transfer of new products to production. This is an individual-contributor position.

Requirements

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.
Lean Six Sigma Experience is a plus.
Computer proficiency
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 to work & deliver results independently
Demonstrates leadership in groups and teams.
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.
Demonstrates exceptional competence in all applicable engineering disciplines.
Demonstrates ability and initiative to mentor Associate / Staff engineers

Nice To Haves

medical device industry experience is a plus
medical device experience in design control is a plus
Lean Six Sigma Experience is a plus

Responsibilities

Develop, improve, and maintain the project management system
Provide 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.
Responsible for specific departmental functions, and performance metrics, as applicable
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
Assist with 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.