Staff Manufacturing Engineer Jobs

Location: Pittsburgh, PA, United States of America
Cardiac Management Solutions
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.
Job purpose
Develop, validate, document, maintain, and support processes, equipment, and process controls to assure that electro-mechanical products meet specifications and applicable regulations. 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 operations 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.
Duties and responsibilities
Responsible for establishing, documenting, validating, training, controlling, and supporting the manufacturing/service process to ensure product can be processed to established quality requirements, timeframes, and costs.
Responsible to understand the appropriate legal and regulatory requirements in the areas of medical device Manufacturing and Service operations and to establish robust processes and controls to ensure compliance.
Responsible to build and improve key business relationships within and outside of Operations.
Ensure operations measurement systems are capable (Gage R&R), process capability (Cpk) is high and process controls are in place to assure that products meet specifications.
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.
May include developing, transitioning, managing, and supporting the launch of manufacturing and service processes remotely, including globally outside of the U.S. Therefore, a willingness and ability to travel up to 10% internationally is a job requirement.
Qualifications
Bachelor of Science degree in Manufacturing, Industrial Engineering, Electrical, Mechanical, or related discipline.
8 plus years of relevant experience in electro-mechanical process development and quality assurance with a proven record of achievement.
Excellent communication and analysis skills, with exceptional attention to detail.
Working conditions
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.
Physical requirements
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 and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.
Supervisory responsibility
None
AAP/EEO Statement
ZOLL is committed to fostering an inclusive workplace, where unique identities, backgrounds, cultures, perspectives and experiences are respected and valued.
Equal Opportunity Employer – Disability and Veteran