Katalyst CRO · 1 day ago
NPD Engineer
Irvine, CA
Full-time
Onsite
Mid Level
4+ years expKatalyst CRO is seeking an NPD Engineer (Medical Device) to support long-term onsite projects in Irvine, CA. The role involves new product development activities, project coordination, and cross-functional collaboration within a regulated medical device environment.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
4–6 years of experience
Medical device component development
Medical Device & Regulations knowledge
New Product Development (NPD) methodology and management knowledge
Strong communication skills with high proficiency in reading, writing, and speaking English
Preferred
Windchill (good to have)
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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