Anteris is seeking a Process Development Engineer II to join our dynamic team in Brooklyn Park, MN. As a PD Engineer, you will play a vital role in the development and improvement of our medical devices' manufacturing processes. The ideal candidate should possess a Bachelor's degree and have a minimum of 2 years of experience working with Class II or Class III medical devices. Help us build a team that will shape the future of TAVR. 

Main Responsibilities:

Process Development and Optimization:

• Develop and optimize manufacturing processes for medical devices, focusing on performance, quality, efficiency. and compliance with regulatory standards.
• Create and implement manufacturing process IMV (Inspection Method Validation), TMV (Test Method Validation), IQ (Installation Qualification), OQ (Operational Qualification), and PPQ (Process Performance Qualification) activities.
• Drive continuous improvement initiatives to enhance product quality, reduce manufacturing costs, and increase productivity through data analysis, root cause analysis, and the implementation of corrective actions.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure seamless integration of new processes into production.

Jig Fixture Automation:

• Design and develop automation solutions and jig fixtures to streamline manufacturing processes and reduce manual intervention.
• Oversee the implementation of automated processes, ensuring compliance with safety standards and regulatory requirements.

Validation and Documentation:

• Prepare and execute validation protocols, including developing testing procedures, data analysis, and generating validation reports.
• Conduct risk assessments and contribute to risk management activities related to the manufacturing process.
• 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).

GMP Compliance:

• Ensure all processes and manufacturing activities adhere to Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
• Collaborate with the Quality Assurance team to address any compliance issues and implement corrective actions.

Cross-Functional Collaboration:

• Work closely with the R&D team to provide manufacturing inputs during product development, ensuring manufacturability and scalability of new designs.
• Collaborate with the Manufacturing team to transfer new processes into production and provide ongoing support for process-related issues.

Basic Requirements:

• Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related).
• Minimum of 2 years of experience in Process Development and Manufacturing Engineering within the medical device industry.
• Knowledge and experience in validation processes (IMV-TMV-IQ-OQ-PPQ) and documentation practices in a regulated environment.

Preferred Qualifications:

• Familiarity with jig fixture automation and process automation techniques.
• 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 communication and interpersonal skills, with the ability to work effectively in cross-functional teams.

Compensation:

Target base salary range: $92,000 – $112,000, plus eligibility for an annual short-term incentive (STI) targeted at 7% of base salary and equity participation. Final compensation will be determined based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

What We Offer:

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Inclusive Team Environment - 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.

Health and Wellness Offerings:

• Medical, Dental, and Vision Plans
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Equity Program
• Paid Holidays & Vacation
• Employee Assistance Program