New Product Development Quality Engineer II
An operations quality engineer supporting new product development and design transfer activities. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will execute activities defined on design for manufacturability, risk management evaluation as well as process validation.
Also provides support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met. Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
- Execute and support on-time completion of Design Control Deliverables
- Accountable for Process Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
- Execute and support Risk Management activities from product Development through Commercialization
- Support design and manufacturing test and inspection method development, and lead method validation activities
- Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Leads technical activities for new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.
- Presents findings and recommendations.
- Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
- Understands engineering principles theories, concepts, practices and techniques.
- Incorporates business policies and procedures into task completion.
- Understands the business needs of the company, and has knowledge of the customer needs of our business.
- Cultivates internal and external network of resources to complete tasks.
- Serves as a resource in the selection orientation and training of new engineers and employees.
- Supports project team(s), determines goals and objectives for the projects.
- Interacts cross functionally and with internal and external customers.
- Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
- Acts as a spokesperson to customers on business unit current and future capabilities.
- Bachelor's degree plus 2-4+ years of related work experience with an understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
- Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
- Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning
- Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements
- Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design
- Training in blueprint reading and experience with sampling techniques
- Good communication and computer skills, including data analysis and report writing skills
JOB FAMILY:Operations Quality
DIVISION:CAHF Cardiac Arrhythmias & Heart Failure
LOCATION:United States > Minnesota : 5050 Nathan Lane N.
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf