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Engineer 3 - Business Excellence (Quality)

2 months ago

Littleton, United States Terumo BCT Full time

Requisition ID: 32180 At Terumo Blood and Cell Technologies, our 7,000 global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours. The Engineer 3 - 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 continuous improvement initiatives 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 Quality Idea Generation Program. 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. Support digital/technology transformation efforts by participating and inputting into activities such as value stream and process mapping to optimize new and changed process and technologies. Lead/Support in identifying LEAN/Continuous Improvement needs along with cross functional business partners and help assess priorities and develop implementation plans. Leads, coaches, and provides oversight of the Quality Idea Generation Program. Assess system effectiveness to identify unplanned training needs/system gaps and assure personnel engagement. 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. Support digital/technology transformation efforts and Center of Laboratory Excellence implementation efforts by participating and inputting into activities such as value stream and process mapping to optimize new and changed process and technologies. 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. Mentors less experienced engineers. 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 activelywith, 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 Bachelor's degree in Business Management, Engineering, or other related field of study. Experience A minimum of 5 years of business operations and/or plant manufacturing or engineering experience, which includes 2 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 preferred 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 precipitatetransformational changes by teaching and coaching on Lean/Six Sigma principles. Strong leadership abilities. Travel Requires domestic and international travel based on business needs. LOCATION Lakewood, Colorado - Open to candidates willing to relocate to the area. PHYSICAL REQUIREMENTS General Labor Environment requirements include;use of personal protective equipment, reading, speaking, hearing, traverse, 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. Typical Office Environment requirements include: reading, speaking, hearing, close vision, traverse, bending, sitting, and occasional lifting up to 20 pounds. 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 accommodation may be made to enable individuals with disabilities to perform the essential duties. Target Pay Range: $107,000.00to$133,800.00 -Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base: 7.0% At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind. Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue. We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. Respect - Appreciative of others Integrity - Guided by our mission Care - Empathetic to patients Quality - Committed to excellence Creativity - Striving for innovation We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007. We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.