Validation Lead Engineer- Irving, TX - Onsite

JOB SUMMARY

• Under the direction of the applicable Engineering Technical Leader, manages most aspects of multiple projects or initiatives.

• Role interfaces directly with other facility and corporate functional groups to ensure that goals and objectives are met within GMP/ISO compliance and product design changes are addressed appropriately.

• Lead multifunctional, cross departmental projects and initiatives geared towards achieving new process/product introductions (NPI), process improvements, cost reductions, and quality improvement.

DUTIES & RESPONSIBILITIES

• Plans, documents, and executes new process development, designed experiments, validations, qualifications, testing, and design control deliverables in order to launch high-quality, compliant new products into manufacturing while meeting time, cost and margin targets.

• Monitors and supports new product processes until stabilized, and fully transferred into production.

• Manages and executes projects and/or programs of moderate to high level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met.

• Provides project management guidance and business tools, utilizing a systematic approach to project execution. Prepares management reports and presentations. Effective project planning and structure.

• Develops creative strategies for the efficient completion of projects.

• Leads the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management in an innovative manner.

• Challenges the status quo on a routine basis and develops new ideas within incoming processes.

• Coordinates phases of work with other departments including R&D, Operations, Regulatory Affairs, Sourcing, Process Excellence, etc.

• Technical support to Manufacturing Business Units for complex process issues, where higher level of technical expertise in a given field of knowledge is required.

• Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations.

• Revise and maintain engineering, equipment and process procedures.

• Coordinates communications and interfaces with end users, machine manufacturers and/or suppliers.

• Writes, develops and implements validation procedures.

• Reviews and analyzes data, understanding of statistics and the application of statistical data, able to determine normal and non-normal data along with probable causes of non-normal results

EXPERIENCE AND EDUCATION

• Bachelor s degree in engineering discipline.

• Six to Eight (6-8) years minimum experience in engineering in a medical device environment preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.

• Advanced computer skills and use of software applications. Strong computer background (MS Office, MS Project Management, PowerPoint, Word, Excel, Outlook etc.)

• Experience in a manufacturing environment developing manufacturing standards.

• Proficient in project management, creating credibility within team members and expanding capabilities of the group.

• Experience or knowledge in short and long-term project management.

• Strong Organizational, interpersonal, oral and written communication skills.

• Ability to prioritize multiple commitments and technical problem-solving duties.

• Ability to shift priorities according to changes in department/facility needs and open to different ideas/approaches.