The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.
Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives.
ZOLL has been Pittsburgh’s Manufacturer of the Year, one of Western PA’s Healthiest Employers, and even one of Pittsburgh’s Coolest Offices. But it’s our unique opportunity to impact people’s lives that makes ZOLL the ideal place to build your career.
Develop, validate, document, maintain, and support processes, equipment, and process controls to assure that electro-mechanical products meet specifications. Develop, implement, and manage value improvement projects which incorporate a Lean/Six-Sigma approach. Provide timely and effective development and implementation of manufacturing standards and process specifications to assure achievement of manufacturing and cost objectives. Implement production testing methods and procedures to assure that products meet specifications. Perform analyses on quality information to proactively improve potential problems and capture improvement opportunities.
Essential Duties and Responsibilities:
- Responsible for establishing, documenting, validating, training, controlling, and supporting the service process to ensure the value stream produces quality product on-time.
- Responsible for process and facility reliability and risk mitigation/reduction.
- Responsible for the development and execution of Lean/Six-Sigma and other total-cost improvement initiatives.
- Responsible to understand the appropriate legal and regulatory requirements in the areas of medical device Service operations and to establish robust processes and controls to ensure compliance.
- Responsible to build and improve key business relationships within and outside the Service organization.
- Responsible to proactively identify net value improvement opportunities in Service operations, facilities, and grounds, and to make continuous improvements.
- Develop, document, and support value stream processes, equipment, and personnel to ensure product can be processed to established quality requirements, timeframes, and costs.
- Ensure Service operations quality measurement systems are capable (Gage R&R), process capability (Cpk) is high and process controls are in place to assure that products meet specifications.
- Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented.
- Analyze and design the sequence of operations and process flow to improve efficiencies in plant and production facilities and equipment layouts; and establish methods for maximum utilization of production facilities and personnel.
- Conduct studies pertaining to cost control, cost reduction, inventory control, and production record systems. On the basis of these studies, develop and implement plans and programs for facility modifications and revisions to operating methods
- Improves job knowledge by proactively engaging in educational opportunities, reading books and professional publications, and/or participating in professional organizations.
- Monitors and follows applicable laws and regulations.
- May include developing, transitioning, managing, and supporting the launch of service processes remotely, including globally outside of the U.S. Therefore, a willingness and ability to travel up to 20% internationally is a job requirement.
Supervisory Responsibilities: None.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
Educations and/or Experience:
- Behavioral: Highly-motivated leader, sets a ‘high-bar’ of achievement for self and organization, actively mentors peers and associates toward high-performance, works outside of functional ‘boundaries’ for the betterment of the company, builds trust with people, overcomes adversity, makes and keeps commitments, keeps stakeholders informed.
- Skills/Qualifications: Enjoys working directly with production/service personnel to support and improve the value stream. Takes an engineered approach to problems. Accurate and extremely detail-oriented; balances both short term emergencies and long term objectives, achieving success in both. Experience with project planning and management.
- Experienced in process development and validation for electro-mechanical assembly, test, and service.
- Understands and has applied in practice the concepts of process capability, process control, and measurement system capability.
- Strong track record of delivering results.
- Bachelor of Science degree in Electrical, Mechanical, Manufacturing, or Industrial Engineering.
- 1-3 years of relevant experience in electro-mechanical process development and quality assurance with a proven record of achievement. Formal project management experience a plus.
- Excellent communication and analysis skills, with exceptional attention to detail.
Language Skills: Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to walk. The employee must occasionally lift and/or move up to 10 pounds.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The noise level in the work environment is usually quiet.
ZOLL is an Equal Opportunity Employer.