Engineer Level 5 – Engineering COE (Center of Excellence)

JOB SUMMARY

This role provides strategy, thought leadership and direction on projects and initiatives focused on Enabling Development Technology, Quality and Regulatory across all areas of the I&D (Innovation and Development) Engineering organization.  Serves as primary cross-functional interface with Quality and Regulatory organizations and works across all areas within  I&D to ensure alignment to COE strategy and objectives.

ESSENTIAL DUTIES

• Develops, implements and communicates protocol, systems and processes to ensure Quality and Regulatory objectives are understood and achieved within I&D and cross-functionally
• Serve as subject matter expert within I&D to help development teams with standardized application of product development tools in the ongoing development of legacy and new products
• Leads and provides coaching, technical oversight and direction to COE team
• Serves as I&D champion on all Quality and Regulatory related goals and initiatives
• Assures tools are developed and implemented for efficient development of new products globally
• Establish and train best practices globally and build strategy to update and manage product DHFs (Design History Files)
• Aligns EUMDR submission needs strategically with existing artifacts and satisfies new data requirements that support future product development / sustaining needs
• Collaborates with I&D and Regulatory resources to establish standards for minimum viable requirements for regulatory submissions
• Lead the development of standardized systems that automate data capture and analysis in a global/searchable database for development of future products
• Supports product evaluation / compliance evaluation to changing regulations and standards
• Establish standardize method to incorporate international and regional standards into product requirements / DHF’s for efficient development and sustaining support
• Recommends the global organization and linkage of DHF artifacts and supporting data

OTHER DUTIES AND RESPONSIBILITIES

• Establish standardized methods for verification to product requirements and outgoing quality expectations at launch
• Collaborates and ensures alignment with key leaders and stakeholders cross-functionally and within I&D
• Anticipates problems, generates technically advanced alternatives and implements innovative solutions for complex problems which require the regular use of ingenuity and creativity
• Understands the impact process change in one area will have on other areas and manages the impact of changes
• Identifies risks and understands how to approach and complete multiple tasks/projects, avoiding major delays in schedules and product introduction or eventual loss of business 
• Work direction responsibility may include technicians and junior engineers

• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor of Science degree or Master of Science degree in Engineering preferred

Experience

• Minimum 15 years’ experience
• Two years of GMP manufacturing experience required

Skills

• Demonstrated ability to interact productively and to effectively influence peers and external colleague and senior management
• Knowledge of FDA regulatory and ISO requirements and trends affecting medical devices
• Experienced with design control methodologies
• Experience with developing medical products in regulated industry
• Demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology

PHYSICAL REQUIREMENTS

General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Requires travel based on business needs.