at Natus Medical in Schaumburg, Illinois, United States
Job Description
POSITION: Design Transfer Engineer - Manufacturing & Service
LOCATION: Schaumburg, IL (Flexible Schedule)
SUMMARY:
In this role, you will take a leading role in the design transfer of product design to manufacturing, depot repair, and service centers, including architecting manufacturing processes and implementing strategies for the delivery of product service and repair to our customers, from early design of new devices to establishing global manufacturing and repair centers. You will act as a key interface between product development, manufacturing engineers, technical service, repair centers, and sales to deliver product to our customers.
ESSENTIAL DUTIES AND RESPONSIBILITIES
*Join NPI and sustaining program teams as the lead for design transfer to manufacturing and service:
oIn collaboration with design team, develop the strategy to manufacture Natus medical devices spanning from electronic assemblies to high-end optical designs.
oDefine service levels, workflow, and repair locations for new and established devices.
oAct as primary technical point-of-contact between product development and internal and external manufacturing and repair sites.
oEnsure appropriate traceability between system, subsystem, process/repair verification and validation, and cross functional deliverables.
oManage manufacturing and service risks using PFMEA.
oWrite, release, and maintain service manual, repair instructions, and troubleshooting guides for new and establish products.
*Establish Service Design Transfer within the R&D Engineering organization as an end-to-end technical expert for repair, service, and maintenance of products.
*Collect and translate design inputs from manufacturing, operations, sales, and service for new product introduction.
*Provide review and input of new design for serviceability and manufacturability.
*Apply ISO 13485, US FDA Quality System Regulations (21 CFR 820), EU MDR and relevant international standards to design activities.
*Coordinate activities with contributors from manufacturing, service, operations, sales, regulatory and quality affairs, marketing, and cross-functional engineering disciplines.
*Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
*Understand, apply, and contribute to the development of quality management system and design controls processes.
*Identify improvement opportunities for the service engineering function and deliverables.
*All other duties as assigned based on changing market conditions, company, and business needs.
Travel Required:
Minimal travel. Up to 15% domestic or international travel.
Supervisory Responsibilities
This position does not have any direct or indirect reports.
QUALIFICATION REQUIREMENTS:
Education and/or Experience
Bachelor's degree from four-year college or university; or two to four years related experience and/or training; or equivalent combination of education and experience. Degree concentration preferred in Engineering or Life Science.
8+ years' experience in medical device design and development within medical device preferred.
8+ years' experience in designing products for manufacturability and serviceability, including creating assembly instructions and service manuals.
Able to work independently with minimal guidance and able to take initiative to complete process improvements and create efficiency through timely task completion.
Ability to work within a fast-paced environment, multiple concurrent projects, and able to prioritize assigned projects.
Initiative, attention to detail, customer focus, and commitment to ongoing process improvement.
Knowledge of medical device technology, applicable quality, safety standards, and regulations.
Manufacturing, service, and repair deployment experience preferred.
Proficiency in information technology: PCs, servers, software, and databases.
Experience with project management preferred.
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer.
Other duties
Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this position. Duties, responsibilities, and activities may change at any given time, with or without notice.
Pay Transparency
Actual compensation offered may vary depending on skill level, experience, and/or education. Natus offers a competitive total rewards package, which includes medical, dental, and vision insurance, 401k employer contributions, paid time off, and much more.
Affirmative Action/EEO statement
Natus is an equal employment opportunity... For full info follow application link.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability.
