Johnson & Johnson MedTech · 14 hours ago
Sr Design Quality Engineer, Life Cycle Management
Irvine, CA
Full-time
Hybrid
Mid, Senior Level
$79K/yr - $128K/yr
4+ years expJohnson & Johnson MedTech is committed to healthcare innovation, aiming to develop smarter and less invasive treatments. The Sr Design Quality Engineer will provide quality technical and compliance expertise for lifecycle management activities, ensuring design control and risk management compliance while collaborating with cross-functional teams to enhance product quality and efficiency.
Hospital & Health Care
Responsibilities
Responsible for ensuring Design control and Risk Management activities, wherever they are performed comply with the requirements of the quality system
Executes Life Cycle Management projects in a cross-functional setting as the design quality engineer core team member
Works on complex problems and provides solutions which are highly innovative and comprehensive
Applies scientific and engineering knowledge to the development and improvement of medical device products, associated processes, and manufacturing equipment as well as associated validations
Works independently and in cross-functional teams (both internal and external) to determine root cause, develop mitigations and corrective and preventative actions for design, process, and manufacturing related issues
Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Owns Post Market surveillance activities
Evaluates manufacturing processes / products and collaborates with R&D, NPI, Sourcing, QA, Manufacturing and Finance teams to lead projects / initiatives to improve quality, productivity and reduce costs
Utilizes the application of six sigma and lean tools and methodologies
Ensures quality conduct of projects including design, data summary and interpretation, reports and review compliance to applicable regulations
Generate written reports and provide technical expertise to related projects
Provide technical support for outside suppliers, vendors, and/or consultants as required
Provide guidance and work direction to other engineers and related project team members
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring personal and Company compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures
Performs other duties assigned as needed
Qualification
Required
A minimum of Bachelor's or equivalent degree in Engineering or area of Scientific discipline is required; An advanced degree is preferred
A minimum of 4 years of related experience
Knowledge working in a highly regulated industry
Familiarity with ISO 13485, specifically Design Control
Interpersonal skills that promote conflict resolution in both personnel and technical contexts
Strong written and verbal communication skills to communicate effectively at all levels
Excellent problem solving/root cause investigation and decision-making skills
Preferred
Medical device industry experience
Manufacturing process IQ, OQ, PQ qualifications as related to medical devices
Working knowledge of applicable requirements related to the MDSAP jurisdictions
Strong project management skills (Microsoft Project, FPX and/or other project management tools)
Benefits
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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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