EPIX Lead Engineer

7239-AMO Puerto Rico Manufacturing Legal Entity•Anasco, PR

40d•Onsite

About The Position

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Leads engineers in the identification and execution of product and process improvement initiatives to ensure business key performance indicators are met. Role influences decisions across the organization, mentors engineers and technical team members, and collaborates with cross-functional stakeholders and external partners to deliver robust, compliant, sustainable solutions. Role interfaces directly with other departments, sites, and corporate functional groups to drive and/or support critical business goals/objectives within GMP/ISO compliance.

Requirements

Bachelor’s degree in Engineering is required.
A minimum of 6 years of related work experience is required.
Project management experience in an engineering environment.
Experience working in a regulated industry.
Demonstrated experience leading process improvement initiatives.
Experience in an engineering function in FDA environment preferred.
Six Sigma certification or extensive experience applying Six Sigma methodologies for analytical problem solving.

Nice To Haves

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

Responsibilities

Lead engineers managing process improvement initiatives to ensure on time delivery.
Allocates, schedules, and tracks engineering resources required to fulfill departmental commitments.
Establish priorities to engineers aligned to business needs
Analyzes project technical requirement and institutes specific guidelines for the immediate engineering activity.
Serves as the initial escalation contact for issue resolution within the defined area.
Acts as a senior technical contributor and key technical voice within the function and cross-functionally; drives technical direction on complex problems.
Partners with cross-functional governance / prioritization forums to scope, plan, and deliver high-value programs aligned to business objectives.
Identifies, proposes, and leads breakthrough/best-practice methodologies and technology improvements to raise capability and performance.
Guides engineers in the delivery of complex engineering projects/programs requiring conceptual evaluation, design, and validation; establishes milestones, resourcing, schedules, risks, and budgets.
Applies standard project management methods and continuous improvement tools (e.g., Lean/Six Sigma) to deliver results and sustain gains.
Performs concept analysis for future capital/expense projects; supports business case development and justification as applicable.
Analyze current processes to identify key opportunities for equipment and process enhancements that improve efficiency, yield, and safety.
Monitor and analyze production data to identify trends and provide actionable insights for continuous improvement.
Mentors and provides technical guidance to engineers and technical team members; builds functional capability, standard work, and technical excellence.
Provides training/support to operations/engineering teams on relevant methodologies, tools, and safe operation/troubleshooting of processes and equipment.
Ensures adherence to applicable regulations, standards, and company policies; maintains the highest standards of professionalism, ethics, and compliance.
Supports EHS and sustainability objectives relevant to assigned scope and initiatives.