Job Description:ITW Medical, a division of ITW, is comprised of two highly respected brands- Coeur and Filtertek, supplying critical filtration and flow control solutions to global OEM’s, serving Surgical, Infusion, Bioprocessing and Diagnostic Imaging end markets.General Accountability:The Senior Quality Engineer will be responsible for validations, scrap reduction and continuous improvement activities. The individual will ensure that projects are implemented, internal/external quality issues are investigated, and root cause and corrective/preventive actions are identified and executed. This position will be responsible assigned locations.Duties and Responsibilities:
New Product Development
Participate in Design Reviews, including Technical Reviews, Feasibility Discussion, and Failure Modes and Effects Analysis (FMEA) creation
Assist in documenting development work including supporting writing specifications for manufacturing or identifying and/or evaluating scientific test results
Manage Implementation and Documentation of IQ, OQ, PQ.
Ensure timely and conclusive validations.
Process Control
Update existing inspection plans, test methods, and standard operating procedures
Conduct sample size determination, statistical analysis, training, and root cause analysis
Take lead in understanding/updating FMEA for new failure modes
Assist in process optimization
Continuous Improvement
Drive and Actively contribute to various manufacturing projects such as process development, cost reduction and quality improvement initiatives
Perform routine engineering assignments of related tasks which are typically a focused portion of larger projects.
Lead cross-functional teams in continuous quality improvement projects, in particular, in scrap reduction and identification and elimination of non-value-added activities
Take lead in collection, review, analysis and trending of quality indicators for monthly and quarterly reviews
Manage and contribute to problem solving teams using standardized investigation processes/tools.
Compliance
Participate in the Internal Audit process and assist in addressing observations
Participate in customer and regulatory body audits
Other tasks and duties assigned
Position Skills and Experience Requirements:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Bachelor’s degree (required) in Biomedical Engineering field (desired).
5+ years related experience (required) in Medical Devices Industry (preferred).
Ability to perform routine design and engineering tasks with some assistance.
Solid understanding of engineering and mathematics principles.
Ability to interpret product requirements from drawings, specifications, blueprints, etc. and to identify and drive corrections of inconsistencies or inaccuracies in same
Able to command use of inspection and measuring instruments such as calipers, micrometers, and tensile strength testers
Highly motivated, detail-oriented, eager to drive needed change in the organization
Demonstrated use of strong analytical, problem solving, and teamwork skills in a leadership role
Able to follow and to provide instructions in all formats: written, verbal, and electronic.
Excellent time management, prioritization abilities, and strong project management skills
Ability to develop, implement, and present strategies to gain support
Strong analytical skills, with 80/20 mindset
Ability to work with and manage complexity/change such that implementation is simplified
Demonstrated ability to analyze data and make sound, enterprise-first, decisions
Excellent interpersonal, communication, and presentation skills
Ability to generate respect and trust from staff and external constituencies along with the ability to work collaboratively with colleagues and staff to create a results-driven, team-oriented, profitable environment
Personally driven and able to motivate others to excel
Ability to use MS Office Tools such as Word, Excel, Project, Access and MiniTab®.
Compensation Information:This compensation range is provided as a reasonable estimate of the current salary range for this role. Compensation depends on relevant experience and/or education, specific skills, market level, other job-related factors, geographic location, and other factors as applicable by law.Pay Range: $90,000-115,000BenefitsBenefits for this role can be seen by visiting www.itwemployee.com. In addition, employees can qualify for vacation, sick, and holiday compensation benefits.Vacation - up to 120 hours of time within first yearSick - up to 40 hours of time within first yearFloating Holiday - up to 8 hours of time within first yearHoliday - 10 paid holidays per year, these holidays are selected by the DivisionITW is an equal opportunity employer. We value our colleagues’ unique perspectives, experiences and ideas and create workplaces where everyone can develop their careers and perform to their full potential.As an equal employment opportunity employer, ITW is committed to equal employment opportunity and fair treatment for employees, beginning with the hiring process and continuing through all aspects of the employment relationship.All qualified applicants will receive consideration for employment without regard to race, color, sex, gender identity, sexual orientation, religion, national origin, age, disability, protected Veteran status or any other characteristic protected by applicable federal, state, or local laws.
