- Drive the continuous improvement activities of a Testing Services team. Balance multiple projects and responsibilities having to do with test lab maintenance, safety, efficiency improvement, and quality enhancement.
- Author and manage JSAs (Job Safety Analysis), SDS (Safety Data Sheets), and other EHS compliance documents.
- Monitor and renew the calibration of various electronic, electrical, and mechanical measurement devices.
- Manage equipment and test material inventory to help with test planning and reordering.
- Independently execute and document System tests to support System verification. Document tests via test methods and test reports. Route documents for approval (strong writing skills)
- Perform Gage R&R studies to validate test methods. Perform IQ/OQ to validate test equipment
- Perform statistical analysis such as: ANOVA, t-test, tolerance interval, normality test, etc.
- Prepare and operate various lab equipment such as Instron mechanical testers, oscilloscope, force gauges, data loggers, etc.
- Some travel may be required depending on the project demands at the time.
- Designs, develops, and implements testing methods and equipment.
- Plans and arranges the labor, schedules, and equipment required for testing and evaluating standard and special devices.
- Provides test area with parameters for sample testing and specifies tests to be performed.
- Compiles data and defines changes required in testing equipment, testing procedures, manufacturing processes, or new testing requirements.
- Responsible for testing all customer samples and for special tests that cannot be performed in the test area.
- Additional tasks as assigned Must Have: Minimum Requirements
- Bachelors degree with 0 years of engineering experience Nice to Have
- Bachelor's Degree in a technical field such as engineering
- 1+ year of medical device Test Engineering experience
- Knowledge and experience with Medtronic's Surgical Operating Unit and products
- Excellent oral and written communication skills
- Ability to effectively manage and prioritize multiple tasks and projects in an ambiguous environment
- Experience with Medical Product verification and FDA guidance.
- Thorough understanding of creating test methods for verifying product requirements and validating test methods (Gage R&R)
- Experience creating IQ/OQ/PQ protocols and executing them.
- Experience with basic statistics and use of Minitab
- Experience working with QA to ensure testing meets Quality and Regulatory needs.
- Experience working with Systems, Mechanical, Electrical and Software engineers when discovering, documenting, and resolving issues.
- Experience using Instron mechanical tester, oscilloscope, force gauges, and LabVIEW
Test Engineer I - North Haven, United States - Medtronic
Description
Test Engineer I – Surgical Operating Unit
Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. We'll approach the market with a unified approach from concept single strategy, capitalize on our global commercial capabilities, and prove the power of our combined portfolio.
With the Medtronic Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of Medtronic and the customers and patients we serve.
This role is based in North Haven, CT and will not be offering relocation assistance.
Careers that Change Lives
Engineers are indispensable to achieving our Mission. That's why we empower you to bring the best of your experience to bear on our market-leading portfolio of innovations. Apply your existing skills and develop new ones, with the training, mentorship and the guidance you need to continue to develop your expertise. With roles in specific business units, as well as at the corporate level, you're sure to find an opportunity to make an impact that's right for you. Today, we're partnering across the industry to confront systemic healthcare challenges – this requires bold leadership. If you want a challenging, energizing, rewarding career that changes lives, join us. Help us bring the next generation of life-changing medical technology to patients worldwide.
A Day in the Life