Process Development Engineer II

Anteris Technologies - Maple Grove, MN

Full-time - Mid Level

Maple Grove, MN

Professional, Scientific, and Technical Services

About the position

The Process Development Engineer II at Anteris Technologies plays a crucial role in the development and optimization of manufacturing processes for Class III medical devices, particularly in the field of Transcatheter Heart Valve interventions. This position involves collaboration with cross-functional teams to ensure the seamless integration of new processes into production while maintaining compliance with regulatory standards.

Responsibilities

• Develop and optimize manufacturing processes for Class III medical devices, focusing on performance, quality, and efficiency.
• Conduct manufacturing process qualification activities, including manufacturing inspection method and test method validation, IQ, OQ, PQ/PPQ to ensure processes meet product specifications and regulatory requirements.
• Optimize, troubleshoot, and drive continuous improvement initiatives to improve product quality, yield, cost-effectiveness, and increase productivity while maintaining compliance with quality standards.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure seamless integration of new processes into production.
• Design and develop manufacturing jigs/fixtures and automation solutions to standardize and streamline manufacturing processes and reduce manual intervention.
• Oversee the implementation of automated processes, ensuring compliance with safety standards and regulatory requirements.
• Prepare and execute validation protocols, including developing testing procedures, data analysis, and generating validation reports.
• Create and maintain comprehensive documentation, such as work instructions, standard operating procedures (SOPs), and process flowcharts, in accordance with regulatory guidelines and Good Manufacturing Practices (GMP).
• Ensure all processes and manufacturing activities adhere to Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
• Utilize tools such as Failure Mode Effects Analysis (FMEA) and root cause analysis to identify and mitigate potential risks in the process.
• Collaborate with the R&D team to understand design requirements and provide manufacturing inputs during early stages of product development, ensuring manufacturability and scalability of new designs.
• Partner with Quality Assurance to ensure all processes are compliant with FDA, ISO 13485, and other relevant standards.
• Collaborate with the Manufacturing Operation team to transfer new processes into full-scale production and provide ongoing support for process-related issues.

Requirements

• Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related field).
• Minimum of 2 years of experience in Process Development and Manufacturing Engineering within the medical device industry, preferably with Class III medical devices.

Nice-to-haves

• Specific experience with Transcatheter Aortic Valve Replacement (TAVR) or Transcatheter Mitral Valve Repair (TMVR) devices is highly desirable.
• Strong knowledge and experience in validation processes (IMV-TMV-IQ-OQ-PPQ) and documentation practices in a regulated environment.
• Familiarity with jig/fixture automation and process automation techniques.
• Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, ISO 14971 and ISO 5840.
• Understanding of Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
• Excellent problem-solving skills and the ability to apply engineering principles to improve processes and solve technical challenges.
• Strong written, communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
• Attention to detail, organized, and able to manage multiple projects simultaneously.
• Proven ability to thrive in a fast-paced, dynamic environment with frequent changes in priorities.

Benefits

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package, including salary, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.
• Medical, Dental, and Vision Offerings
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Stock Option Plan
• Paid Holidays & Vacation
• Employee Assistance Program
• Inclusive Team Environment