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Product Development Engineer
2 months ago
We are seeking a highly skilled Product Development Engineer to join our team at Medical Device Manufacturing Co. As a Product Development Engineer, you will play a critical role in the design and development of our medical devices.
Key Responsibilities- Participate in the design and development of medical devices that meet regulatory requirements and are safe and effective.
- Collaborate with cross-functional teams to generate novel and innovative medical device design concepts.
- Develop and maintain regulatory compliant documentation for inclusion in the design history file.
- Conduct design verification and design validation activities to ensure compliance with regulatory requirements.
- Perform statistical analysis of test results to inform design decisions.
- Translate design inputs into design outputs and present work at cross-functional design reviews.
- Participate in and generate documentation for cross-functional risk management activities.
- Bachelor's degree in mechanical engineering or equivalent.
- Proficient in CAD software (SolidWorks preferred) and MS Office.
- Experience in design of injection molded plastic parts and assemblies.
- At least one year of relevant experience in the medical device industry.
- High attention to detail and ability to work collaboratively with other departments.
Working conditions are normal for an office environment. Work may require weekend and evening work, travel, and physical activity including walking, standing, bending, squatting, reaching above shoulders, and lifting up to 40 lbs.
