CMS
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.
Essential Functions- 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.
Required/Preferred Education and Experience- Bachelor's degree in Manufacturing, Industrial Engineering, Electrical, Mechanical, or related discipline required.
- 5 to 8 years of relevant experience in electro-mechanical process development and quality assurance with a proven record of achievement required.
Knowledge, Skills and Abilities- Excellent communication and analysis skills, with exceptional attention to detail.
Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Standing - Occasionally
- Walking - Occasionally
- Sitting - Constantly
- Talking - Occasionally
- Hearing - Occasionally
- Repetitive Motions - Frequently
The annual salary for this position is:
$80,000.00 to $100,000.00
Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.
