Manager, R&D Verification & Validation (V&V) & Lab Ops

Johnson & Johnson Innovative Medicine•Irvine, CA

1d•$117,000 - $201,250•Onsite

About The Position

We are searching for the best talent for a Manager, R&D Verification & Validation (V&V) and Laboratory Operations. The position is based in Irvine, CA. Purpose: The Manager, R&D Verification & Validation (V&V) and Laboratory Operations leads V&V of ophthalmic devices and manages day-to-day lab and compliance activities. This people leader is responsible for overseeing the administration, hiring, training and development, and managing the professional/performance goals of the team. The Manager, R&D V&V and Labs manages people, resources, test planning/execution, lab equipment and calibration, and compliance with Quality System Regulations. This position requires technical and leadership skills to advance the development of medical devices before and during V&V activities. Will be acting as the advisor to resolve technical or operational problems during product development. Uses current practices, standards, and experience to establish operating policies and procedures that are compliant with Quality System Regulations. Also responsible for managing the R&D lab equipment, safety regulations, equipment calibration, and internal/external audits. Adheres to environmental policy, procedures, and supports department environmental objectives.

Requirements

A Bachelor’s Degree in engineering is required
10+ years of medical device test, V&V, and/or QA experience
2+ years of direct people management
Experience managing V&V teams within the Medical Device industry
Excellent understanding of design control, requirements management, configuration management, product software V&V, defect management and software risk analysis
Knowledge of ISO 14971, 21 CFR 820
Excellent organizational skills including attention to detail and multi-tasking skills is required
Outstanding communication and presentation abilities
Experience in project management, scheduling, tasking, and budgeting

Nice To Haves

Chemistry, Manufacturing, and Control (CMC)
Clinical Trial Protocols
Developing Others
Give Feedback
Inclusive Leadership
Industry Analysis
Job Scheduling Software
Laboratory Operations
Leadership
Market Research
Performance Measurement
Process Improvements
Product Development
Product Strategies
Research and Development
Team Management

Responsibilities

Provide quality and technical leadership to ensure new medical devices meet their intended use.
Lead planning and execution of verification and validation for new products.
Ensure resourcing is available to complete all assigned V&V projects.
Collaborate with product engineering to define and review requirements, design verification, white-box and black-box test strategies.
Oversee test development, execution, defect tracking, and closure; approve test artifacts and deliverables.
Implement and continuously improve V&V processes, tools, and metrics.
Manage lab facilities: equipment procurement, maintenance, calibration, and safety compliance.
Lead internal and external audits and support regulatory submissions and inspections.
Mentor and develop a multidisciplinary team; conduct performance management and hiring.
Maintain documentation in accordance with design control and configuration management requirements.
Ensure software risk analysis and defect management practices are in place and followed.
Support department environmental and safety objectives.
Engage in Credo-based decision-making and interact with team members both local and off-site.
Drive efficiency through test automation, AI, onshore/offshore contract services, and related initiatives
Participate in design for test/manufacturing/reliability efforts
Partner with reliability testing
Have scope including hardware, software, and consumables
Prioritize and execute capital spending

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)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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