Quality Engineer III, Nordson MEDICAL at Nordson Corporation

Posted in Other 17 days ago.

Location: San Jose, California





Job Description:

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



  • Able to construct plan for a complete project, system, component, or process. Prepares complete project documents. Designs and conducts experiments and analyzes and interprets data. Formulates and solves problems.

  • Reviews complete project documents for conformity and quality assurance. Develops new techniques and/or improved processes, materials, or products. Assists upper-level management and staff as a technical specialist or advisor.

  • Investigates and evaluates material biocompatibility and appropriate methods of sterilization if applicable.

  • Designs and implements product and process documentation, including inspection plans.

  • Conducts feasibility studies of the design to determine ability to function as intended.

  • Maintains detailed documentation throughout all phases of research and development.

  • Conducts risk analysis for products under development.

  • Ensures outside supplier quality systems meet Nordson's requirements and coordinates any activities with the supplier as needed.

  • Develops verification and validation test protocols.

  • Develops product submission documentation if required by the customer.

  • Receives general direction on key objectives.

  • Receives guidance on complex problems, direction on modified techniques, and new approaches on assignments with conflicting criteria.

  • Any other duties as assigned.

  • May assign tasks to and direct engineers, technicians and administrative staff. May plan and coordinate detailed aspects of the Quality Assurance / Quality Engineering work. Prepares scope, budget, and schedules for required QA activities within individual projects. Assists with proposals to provide professional services or cost estimations for engineering projects or programs.




Education and Experience Requirements



  • Bachelor's degree in Engineering or equivalent.

  • Minimum 5 years of medical device product design and development experience, required.

  • Familiarity with FDA QSR and ISO 13485 medical device regulations.

  • Familiarity with Minitab or similar data analysis package.

  • Knowledge of probability and statistics.

  • Depth of knowledge in one or more clinical, product or technical areas.




Skills and Abilities



  • Demonstrated ability to bring products from concept to market.

  • Ability to interact with client companies in a professional manner.

  • Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.

  • Possesses advanced oral and written communications skills.

  • Ability to effectively interact with customers, officials, contractors, and others. Expected to attend project meetings and present specific aspects of Quality Assurance and Quality Engineering assignments.




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



None


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.
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.