Manufacturing Process Engineer for Medical Devices

5 days ago


Osseo, Minnesota, United States Anteris Tech Full time
Job Overview
An experienced Manufacturing Process Engineer is sought to join the dynamic team at Anteris Technologies, a science-driven structural heart company. As part of our innovative environment, you will contribute to the development and improvement of medical device manufacturing processes.

About Us
Anteris Tech is redefining expectations in the healthcare industry with cutting-edge solutions focused on restoring native-like physiology. Our team consists of experts who share a passion for advancing therapies through collaboration and innovation. With offices across the globe, we strive to foster an inclusive work environment that promotes growth and excellence.

Salary
The estimated salary range for this position is $85,000 - $120,000 per year, based on location and experience. A competitive compensation package, including performance-based bonuses and stock options, is also offered.

Key Responsibilities
This role involves developing and optimizing manufacturing processes for Class III medical devices, ensuring compliance with regulatory requirements and quality standards. Some key responsibilities include:
  • Designing and developing manufacturing jigs/fixture and automation solutions to standardize processes and reduce manual intervention.
  • Overseeing the implementation of automated processes, ensuring safety standards and regulatory compliance.
  • Preparing and executing validation protocols, including testing procedures, data analysis, and validation reports.

Requirements and Qualifications
To be successful in this role, candidates should possess a Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related field) and a minimum of 2 years of experience in Process Development and Manufacturing Engineering within the medical device industry. Additionally, familiarity with FDA regulations, ISO 13485, and Good Manufacturing Practices is highly desirable.

Benefits
At Anteris Tech, we offer a comprehensive benefits package, including medical, dental, and vision offerings, flexible spending account, 401k + company match, life insurance, short-term disability, long-term disability, bonus plan eligibility, employee stock option plan, paid holidays & vacation, employee assistance program, and an inclusive team environment.

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