Johnson & Johnson MedTech · 6 days ago
R&D Principal Engineer - Electrophysiology
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$117K/yr - $201K/yr
8+ years expJohnson & Johnson MedTech is focused on healthcare innovation and developing personalized treatments. The R&D Principal Engineer will lead life cycle management projects, focusing on cost improvements and ensuring compliance with technical and regulatory standards.
Hospital & Health Care
Responsibilities
Lead the R&D work-stream on life cycle management (LCM) projects that will primarily focus on cost improvements
Work with other engineers and cross functional partners in supporting existing product improvement
Own Design History Files for LCM projects
Own Design Requirements and ensure the design and design's validated state complies with technical, quality, and regulatory compliance
Qualification
Required
8 to 10 years of experience, preferably related to the position
University/Bachelors Degree in Engineering or Equivalent
Strong knowledge of the medical device industry and manufacturing technologies
Familiarity with quality and regulatory systems including FDA's Quality System Regulation, ISO13485, etc
Must have extensive experience in leading projects, developing processes, test methods, and in documentation writing
Experience with tools and equipment for product design and manufacturing
Demonstrated experience developing technological solutions for medical device products
Proficiency in SOLIDWORKS and Design of Experiments (DOE)
Familiarity with design control, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA)
Ability to operate independently and adapt to changing requirements
Ability to work in a fast-paced environment, managing multiple priorities from different projects
Ability to travel 25% - 35% (Domestic and International)
Preferred
Masters Degree or greater is preferred
Coaching
Contract Management
Critical Thinking
Design Thinking
Fact-Based Decision Making
Feasibility Studies
Incident Management
Mechanical Engineering
Organizing
Process Oriented
Product Development
Project Management Methodology (PMM)
Project Support
Research and Development
SAP Product Lifecycle Management
Technical Credibility
Technical Writing
Vendor Management
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
This position is eligible to participate in the Company’s long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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