Business Excellence

Title: Business/Operational Excellence

Type of Hire: Direct Hire

Location: Lakewood, CO

Relocation : Yes

Important Notes: 10% Travel (Domestic & International)

Must Haves: Bachelor's Degree in Engineering, Expert in Business Processes, Improving Business Processes across the globe, Will handle all Departments (Manufacturing, Operations, Finance, Human Resources, Strategical Planning), Able to breakdown complex issues/processes to determine both good processes and bad processes, Black Belt LEAN/Six Sigma is a huge plus, Proven track record of improving processes and Data Analytics.

JOB SUMMARY

Business Excellence works in collaboration with Operational Excellence and cross functional business partners to assess, improve and streamline existing quality management system (QMS) processes for the efficient execution of key strategic business initiatives. Acting as the Quality Leader driving the business excellence program for global sites, this role delivers sustainable improvements in product quality, management systems and services by participating in or leading improvement projects using continuous improvement methodologies. Creates/ delivers appropriate LEAN/CI education to create and sustain a continuous improvement culture. Support digital technology and Laboratory Center of Excellence transformation and remediation efforts. Leads and provides coaching, oversight and direction of the Business Excellence and Six Sigma Training Programs and Kin-Shitsu Projects.

Critical aspects of this role include:

• CPM reduction
• Driving operational excellence across factories by partnering with Operations
• Teaching non-factory associates to think about and drive continuous improvement

ESSENTIAL DUTIES

• Utilizes PDCA (Plan-Do-Check-Act) and DMAIC (Define-Measure-Analyze-Improve-Control) methodologies to actively participate in continuous improvement projects that impact product quality and services, and aligns quality management system processes with current business requirements for the successful execution of key business strategic initiatives and develop new processes that have a significant impact on multiple disciplines.
• Applies E3 concept (Engage, Enable, Empower) within project activities to ensure project sustainability with affected work force, supervisors, and leaders.
• Provide leadership and guidance to cross functional managers to deliver site specific improvements using Lean and continuous improvement methodology and tools.
• Lead/Support in identifying LEAN/Continuous Improvement needs along with cross functional business partners, and help assess priorities and develop implementation plans.
• Leads projects to improve business processes by utilizing key operational excellence tool sets.
• Leads, coach and provide oversight of 6 Sigma Training Program. Assess system effectiveness to identify unplanned training needs/system gaps. Gathers and analyzes data for monthly reporting regarding metrics, performance, and progress of ongoing projects.
• Perform audits and assessments for the evaluation of implemented improvements and consistency across global sites.
• Displays accessibility and sought out for consultation on a broad range of complex technical and industry issues engineering staff and management.
• Works on complex issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
• Keeps updated on recent technical advances within the industry and applies this knowledge to products and processes.
• Contributes to the establishment of business objectives, goals, budgets, and costs as requested.
• Mentors less experienced engineers.

OTHER DUTIES AND RESPONSIBILITIES

• Collaborates and ensures alignment with key leaders and stakeholders cross-functionally and within Quality.
• Anticipates problems, generates technically advanced alternatives, and implements innovative solutions for complex problems which require the regular use of ingenuity and creativity.
• Works on significant and unique issues where analysis requires evaluation of intangibles. Exercises independent judgment in selecting methods, techniques, and evaluation of criteria for obtaining results.
• Engages actively with, inspires, and drives the effectiveness of teams that integrate multiple functions/disciplines and have broad business impact.
• 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

• BS/BA degree in Business Management, Engineering, or other related field of study.

Experience

• A minimum of 8 years of business operations and/or plant manufacturing or engineering experience, which includes 3 years of demonstrated process improvement program success.
• Two years of GMP manufacturing experience required. Knowledge of FDA regulatory and ISO requirements and trends affecting medical devices and drug combination products preferred.
• Black Belt LEAN /Six Sigma certification training or comparable, or must be able to complete within first year.
• Professional communication skills and proven leadership capabilities.
• Project management experience and certification preferred.
• Experience in development/assessment of automated and manual assembly manufacturing processes.
• Proficiency in Microsoft Team, Excel, Power Point, Minitab (requirements) and Power BI (preferred)

Skills

• Demonstrated ability to interact productively and to effectively influence peers and external colleagues and senior management.
• Skilled in influencing/motivating teams and stakeholders across different sites and cultures.
• Experience with assessing, implementing, and training engineering best practices.
• Knowledge of FDA regulatory and ISO requirements and trends affecting medical devices and drug combination products.
• Coaching and communications skills
• Ability to identify opportunities where a small change can precipitate transformational changes by teaching and coaching on Lean/Six Sigma principles.
• Strong leadership abilities.

Additional Physical Requirements

Requires domestic and international travel based on business needs.