Senior Manufacturing Engineer

Anteris Tech•Maple Grove, MN

22d•$120,000 - $135,000

About The Position

Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. We are seeking a Senior Manufacturing Engineer to provide technical leadership for biologic tissue manufacturing processes supporting our next-generation structural heart technologies. This role is responsible for ensuring that tissue processing operations are robust, scalable, validated, and compliant as the organization advances toward pivotal clinical milestones and commercial readiness. This individual will serve as a Subject Matter Expert (SME) in biologic tissue handling, chemical processing, and cleanroom manufacturing, partnering closely with R&D, Quality, Regulatory, Supply Chain, Process Development, and Production. The role combines hands-on engineering support with strategic process ownership, ensuring that tissue manufacturing processes meet the highest standards of quality, regulatory compliance, and operational efficiency. At Anteris Technologies, you will join a mission-driven team dedicated to improving the lives of patients with structural heart disease through breakthrough biomimetic valve technologies — and play a critical role in building the manufacturing foundation that supports that impact.

Requirements

Bachelor’s degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, or related STEM discipline required; advanced degree preferred.
5+ years of manufacturing engineering experience in medical devices, biologics, or regulated cleanroom manufacturing.
Strong knowledge of: cGMP and FDA Quality System Regulation (21 CFR 820), ISO 13485 quality systems, Risk management principles (ISO 14971), Statistical process control and data analysis
Experience supporting IQ/OQ/PQ and process validation activities.
Excellent technical writing and documentation skills.
Strong cross-functional collaboration and communication abilities.
Ability to balance strategic process ownership with hands-on engineering support in a cleanroom environment.
High attention to detail and strong commitment to quality and compliance.

Nice To Haves

Direct experience with biologic tissue processing, implantable medical devices, or aseptic manufacturing environments strongly preferred.
Familiarity with biologic tissue handling, chemical processing systems, or aseptic manufacturing environments preferred.
Experience with structured root cause investigation and problem-solving methodologies such as 8D, DMAIC, or similar frameworks.

Responsibilities

Establish and maintain the Device Master Record (DMR) for tissue-based products, including specifications, manufacturing procedures, production travelers, BOM structures, ERP configurations, and associated documentation.
Define, measure, and control Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) for biologic materials and tissue processing operations.
Conduct process capability analyses, GR&R studies, and statistical assessments to ensure process robustness and repeatability.
Lead initiatives to scale tissue processing from clinical to commercial manufacturing.
Drive improvements in yield, scrap reduction, and cycle time optimization.
Develop, execute, and maintain validation activities across the product lifecycle, including process, equipment, inspection, test method, and cleaning validations.
Own risk management documentation for tissue processes, including FMEA and PFMEA.
Partner with Quality to ensure validation strategies align with the Quality Management System and regulatory expectations.
Collaborate with Regulatory Affairs to ensure validation documentation supports global regulatory submissions and compliance requirements.
Provide hands-on engineering support for cleanroom tissue processing operations.
Troubleshoot complex process deviations, nonconformances, and CAPAs related to biologic material handling.
Lead engineering investigations related to biologic processing issues, manufacturing deviations, and quality events.
Own change management activities for process improvements, equipment modifications, and manufacturing documentation updates.
Develop and continuously improve SOPs, manufacturing procedures, batch records, and technical documentation.
Specify, procure, and qualify tissue processing equipment, tooling, and fixtures.
Define calibration and preventive maintenance requirements for production equipment.
Partner with Facilities and Maintenance to ensure environmental and utility controls support biologic processing requirements.
Design and improve fixtures, tools, and workstations to enhance process repeatability, ergonomics, and operator efficiency.
Collaborate with R&D during design transfer to ensure manufacturability of tissue-based components.
Support internal and external audits, including FDA and notified body inspections.
Provide technical input and data to support regulatory submissions and process validation documentation.
Interface with suppliers of biologic materials, chemicals, and processing consumables to ensure material quality and process compatibility.
Lead continuous improvement initiatives within tissue manufacturing using Lean and Six Sigma methodologies.
Implement data-driven monitoring systems to track and improve process performance.
Mentor junior engineers and technical staff, helping develop the next generation of manufacturing talent.