- Serve as the next-level of technical support for all product design-related matters related to released manufactured products and purchased components.
- Lead efforts to perform root cause analyses, resolve issues, implement product and manufacturing process changes, modifications, and design enhancements.
- Investigate and resolve corrective and preventative actions using appropriate problem-solving techniques (DMAIC, FMEA, Ishikawa, 5-Whys, etc.).
- Track product issues, drive effective and swift resolution, and monitor metrics associated with the team's work.
- Support the implementation and maintenance of processes utilized in internal and external manufacturing, and depot repair and field service activities. Prevent and/or respond to production stoppages due to supplier, process, or quality related matters.
- Drive continuous improvement and Value Engineering initiatives on released product.
- Lead team efforts aimed toward improving customer satisfaction, product quality improvement, manufacturing yield improvement, reducing product variability, and reducing the cost of goods sold.
- Provide engineering support for component obsolescence issues.
- Provide engineering support for product compliance and safety (IEC 60601, REACH, ROHS, CE, etc.).
- Support change management across Natus Neuro's product lines, including drafting and coordinating the implementation of Engineering Change Orders.
- Support the design and testing of new products via effective Design for Manufacturing feedback.
- Deliver medical device design documentation compliant with FDA design controls, good documentation practices, ISO 9001, and ISO 13485.Maintain medical device Design History Files and Device Master Records.
- Support the development, change, and release of design documentation according to the Natus Quality Management System, including design artifacts such as BOMs, drawings, pFMEAs, dFMEAs, work instructions, and manufacturing procedures.
- 5years of sustaining engineering experience, preferably in the medical device industry manufacturing electro-mechanical products.
- Experience with component obsolescence issues required
- Strong project management and organizational skills.
- Ability to work with electronics, PCs and operating systems (understanding and proficiency), and MS Office applications including MS Project
- Ability to read schematics and other electrical/electronic engineering documentation.
- Lean Six Sigma Black Belt or Green Belt;
- Knowledge of SMT manufacturing processes;
- Experience with LabView or other test software language/platforms;
- Knowledge of regulatory requirements in medical device industry;
- Experience in FDA Quality System Regulations, Current Good Manufacturing Practices, risk management (ISO 14971], and Quality Management Systems for Medical Devices [ISO 13485];
- Experience in human factors engineering and usability engineering for medical devices [IEC , IEC 62366, ANSI/AAMI HE75] and medical device safety standards [IEC 60601].
- Agile
- Medical, Dental, Vision
- 401K Match
- 7 paid holidays2 floating holidays of your choosing
- Generous paid time off plan (4 weeks to start- hours accrued)
- Tuition reimbursement assistance eligibility after your first year
- And more
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Senior Sustaining Engineer - Middleton, United States - Natus Medical
Description
Senior Sustaining EngineerMiddleton, WI (In-Person Role)
TheSenior Sustaining Engineer is a crucial team member, who will lead product engineering and continuous improvement efforts, as well as, provide key voice-of-manufacturing and voice-of-customer feedback to guide new product designs, in the maintenance and sustainment of Natus' Neuro products.
This engineer will be the focal person for all technical and product sustaining issues in manufacturing, depot and field service, and for providing project management and technical leadership for changes, enhancements, and extensions of current products. This role will provide technical leadership and mentoring to the greater Sustaining Engineering team and act as a technical consultant to support medical device issues and our network of stakeholders.
The successful candidate must be highly organized with prior experience in manufacturing sustaining roles including robust knowledge of mechanical, electrical, systems, and test engineering, and will use these strengths to help drive issue resolution in collaboration with cross-function teams.This candidate must also be able to succeed in an entrepreneurial environment and not be hindered by ambiguity or competing priorities. This role is heavily slanted toward product sustaining, ie. dealing with everything that arises during the years of manufacturing a product such as component obsolescence, design changes required to improve performance/aesthetics/marketability/etc., quality concerns (yield improvement), product cost improvement, field issue investigations, etc.This type of engineer will be required to often change the product design to meet the new need.. including mechanical and/or electrical changes
What you'll get to do in this role:
Bachelor's degree (B.S.) from an accredited, four-year university or college in electrical, mechanical, systems, or biomedical engineering, or similar degree.
Compensation and Benefits: Comprehensive benefit package that starts on your 1st day Including:
EEO Statement:Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.
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