Senior Product Management Engineer

About Sustainability Solution

The Johnson & Johnson Medical Devices Companies (JJMDC) are committed to helping health systems reduce expenses and decrease environmental impact while meeting or exceeding OEM medical device functional requirements. Offering reprocessed single-use devices manufactured by Sterilmed, Inc., a part of the Johnson & Johnson Family of Companies, is one way in which we fulfill this commitment. As a leading provider of reprocessing services, in addition to reprocessing devices originally manufactured by members of the JJMDC, we also offer reprocessed products from the other original manufacturers, to provide customers with more options to meet their needs.

Purpose

This role focuses on managing and leading cross functional teams to transfer New Reprocessed Medical Devices into production. The position partners closely with R&D, Quality, Technical Lifecycle Management and External Manufacturer to design reliable, repeatable processes and/or equipment to ensure high-quality production through data-driven analysis, validation, and troubleshooting. The role also includes process development, root cause analysis, and continuous improvement of manufacturing processes, along with authoring and maintaining validation and documentation to support regulated environments.

Responsibilities

• Serve as project manager of a multifunctional team to drive new product development activities from production readiness to launch.
• Plans validation strategies and owner of Master Validation Plan for New Product Introduction.
• Proposes and determines new or improved technologies to enhance product quality, manufacturing cost efficiencies, personnel safety and regulatory compliance. Oversees timely completion of pilot operations consistent with new product production activities of the department.
• Work closely with research and development team to develop processes that are manufacturable for new product.
• Develops project scopes, budgets and schedules for assigned projects and develops engineering specifications and documentation for manufacturing equipment. Ensures equipment is qualified/validated and supports safety and environmental initiatives.
• Develop and validate test methods for reprocessing of assigned devices.
• Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and validation.
• Familiar with all aspects of medical device product development, including design, verification and validation, FDA submission, and design transfer into manufacturing.
• Author, revise, train, and provide support for production work instructions.
• Responsible for communicating business-related issues or opportunities to next management level

Qualifications

• BS or MS Degree in Biomedical, Mechanical, Electrical Engineering or equivalent
• Minimum of 4 to 6 years of increasingly responsible product/process engineering experience
• Experience with DOE, FMEA, GMP, and QSR
• Experience in the medical device industry
• Solidworks knowledge preferred
• Proficient in Microsoft Office and Microsoft Project
• Ability to work within an ISO structured quality system
• Good planning, multi-tasking, and project management skills
• Ability to function independently as well as part of a team
• Excellent written and oral communication skills

Skills

• Agile Decision Making
• Coaching
• Corrective and Preventive Action (CAPA)
• Critical Thinking
• Emerging Technologies
• Issue Escalation
• Lean Supply Chain Management
• Problem Solving
• Process Control
• Process Engineering
• Product Costing
• Product Improvements
• Science, Technology, Engineering, and Math (STEM) Application
• Situational Awareness
• Technical Research
• Technologically Savvy
• Validation Testing
• Vendor Selection

Pay

$94,000.00 – $151,800.00

Schedule

Hybrid (2 days remote and 3 days onsite)

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 period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• Long-term incentive program

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits