Senior Manufacturing Engineer - Nordson MEDICAL
Nordson Corporation

Collaboration drives Nordson's success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.

Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart. Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL works with doctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond.

Essential Job Duties and Responsibilities

• Utilize project management skills to drive continuous improvement initiatives to optimize yield, quality, cycle time and ergonomics
• Develop process controls for production equipment, write equipment standards. Specify maintenance and calibration requirements making sure of appropriate quality tools, such as DOE, SPC, hypothesis testing and capability studies to measure, monitor, improve and control manufacturing processes
• Provides technical support for continuous improvement efforts conducting root cause analysis then formulating and implementing corrective action plans
• Work with New Product Development Team - assess and provide input to projects in the hopper to be transfer to manufacturing, ensuring the introduction of a capable and efficient operation
• Support company goals and objectives, policies and procedures, cGMP and FDA regulations by working within and maintaining ISO 13485 systems, including pre-production and post-production compliance in coordination with the Document Control, Regulatory and Quality compliance requirements
• Performs research on technology, equipment and tooling to improve process quality, yield and cost; Generates proposals for purchase and implementation, including cost of ownership, ROI and benefit analysis
• May be required to act as Business Excellence lead in Lean Six Sigma/Continuous Improvement of significant scope and complexity
• Demonstrates complete understanding of a wide application of technical principles, theories and concepts in a manufacturing process technology - has general knowledge of other processes technologies and provides technical solutions to a wide range of difficult problems

Education and Experience Requirements

• Education: Bachelor of Science in Engineering or related Technical/Science field
• Experience: 5+ years Medical device experience or equivalent experience in a regulated industry

Skills and Abilities

Preferred Skills and Abilities

• Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485 and other medical device related standards
• Experience with line layout, line balancing, and capacity analysis
• Knowledge in Lean Manufacturing & Six Sigma Methodologies
• Application of Statistical and analytical methods such as SPC, DOE, and FMEA
• Mechanical aptitude and strong problem solving and troubleshooting ability

Working Conditions and Physical Demands

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Travel Required

Minimal

Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.

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Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.

This job has expired.