NPD Engineer
Katalyst Healthcares & Life Sciences7 months ago
Irvine, CA, United States
On-site
Full-time
Junior Level (1-3 years)
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).
- Author 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
Required Skills
Problem-solving
Project management
Cross-functional collaboration
Strong communication skills
Verification and validation
Medical device component development
Regulatory compliance