4-6 years of experience in new product development, specifically in medical devices.
Strong understanding of medical device regulations and NPD methodology.
Experience with medical device component development is essential.
Basic knowledge of Windchill (preferred but not required).
Proficient communication skills in English, both oral and written.
Responsibilities
Perform project management tasks, including planning and scheduling to ensure timely delivery.
Conduct troubleshooting, debugging, and root cause analysis post product transfer.
Collaborate with cross-functional teams to align on testing strategies and project timelines.
Coordinate product configurations and versions for testing across multiple projects.
Lead component development, engineering builds, and validation processes following the Ethicon change control system.
Drive line transfer activities with strategic planning and logistics management.
Critically evaluate test protocols and reports to ensure quality and compliance.
Benefits
Opportunities for continuous learning and professional development.
Exposure to a dynamic medical device environment with hands-on involvement in innovative projects.
Possibility of travel to various manufacturing plants, enhancing industry experience and network.
Collaborative work culture that supports cross-functional teamwork and synergy.
Full Job Description
Job Summary:
We are looking for an NPD Engineer (Medical Device) to support long-term onsite projects in Irvine, CA.
The role involves new product development activities, project coordination, cross-functional collaboration, and supporting engineering build, verification, validation, and line transfer activities within a regulated medical device environment.
Strong communication, multitasking, and problem-solving skills are essential.
Roles & Responsibilities:
Perform project management activities including planning, developing, and tracking schedules, and ensuring effective communication.
Conduct characterization, debugging, root cause analysis, and troubleshooting for issues post transfer.
Collaborate with cross-functional teams to gain alignment on project plans and testing strategies.
Coordinate with other projects to determine product configuration strategies (including deciding which version of each product will be tested).
uthor and lead activities such as component development, engineering builds, verification, and validation through the Ethicon change control system.
Drive activities for each line transfer, including tactical planning and logistics to navigate obstacles.
Coordinate with team members executing the transfer and support line transfer execution.
Critically review test protocols and test reports.
Travel to different manufacturing plants as required.
Lead or support other LCE projects as needed.
Demonstrate strong generic managerial skills where applicable.
Effectively multitask, understand customer requirements, retrieve relevant information, and provide timely responses.
Follow complex written procedures and function effectively in a team environment to deliver on team objectives.
Make decisions and solve problems while exhibiting strong situational judgment.
Experience:
Experience Required: 4-6 years
Essential Skills: Medical device component development
Desirable Skills: Windchill (good to have)
Domain Knowledge: Medical Device & Regulations, New Product Development (NPD) methodology and management
Strong communication skills with high proficiency in reading, writing, and speaking English
