Manufacturing Quality Engineer II

Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia. Help us build a team that will shape the future of TAVR.

The Manufacturing Quality Engineer II provides Manufacturing Quality support to the development, commercialization, and on-going manufacturing of an implantable medical device system. This position will be a key stakeholder to ensure robustness in manufacturing, process development, validation, risk management and continuous improvement. This person will work cross functionally with Anteris engineers to ensure Anteris, and external regulatory requirements associated with manufacturing controls are met and sustained. This role will sustain the Manufacturing Quality requirements and execution will range from consultation, to performing critical reviews, and completing various Manufacturing Quality deliverables

Primary Responsibilities:

• Work with R&D, design engineering, process engineering and manufacturing engineering departments to develop, conduct and approve product and process validation strategies of products and processes
• Support TAVR valve manufacturing and Tissue characterization
• Participate in nonconformance meetings as a member of the cross-functional MRB team
• Conduct and support investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs) and customer complaints
• Define sampling plans and approves inspection methods for evaluation and acceptance of in-process and finished product
• Revise, approve, and support execution of IQ, OQ, PQ, TMV or software validation
• Escalation of quality problems when applicable
• Provide support in the analysis of products related to product testing, field issues, to determine failure modes and corrective actions
• Provide support in the resolution of complex problems (technically) associated with the manufacturing process
• Revise / analyze if the current products and processes (including taken actions or decisions) comply with the regulations, such as FDA CFR 820, ISO 13485, 14971, etc. including providing support during internal and external audits
• Analyze / check the effectiveness of preventive and corrective actions
• Maintain and periodically revises the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer
• Develop, maintain and check that the measuring methods are appropriate for the manufacturing processes
• Provide support in the revision and maintenance of PFMEAs, Quality control plans, process instructions and additional manufacturing documents
• Develop, interpret and properly implement process monitoring and control methods consistent with the process/product risk level
• Evaluate and interpret common variation causes vs special in the manufacturing process and determine the adequacy of the current process limits
• Evaluate the need of risk mitigation techniques given product classification, potential types of defects, defect frequency, severity, risk for the patient, process capacity, process controls, etc.
• Determine the effectiveness of these techniques in the previously implemented improvements
• Own the risk assessment process including the realization, documentation, revision or maintenance of the current risk and documentation of the risk assessment such as FMEA of the process given the changes in the product/process
• Participate in audit preparation activities for/or interactions with regulatory agencies (FDA, BSI, etc.)
• Respond to internal or external audit observations related to the Manufacturing Quality Engineering function
• Properly establish and maintain the required documentation of quality assurance activities and/or quality systems
• Perform periodical audits of the manufacturing process to evaluate GMPs, production controls, lot segregation and process controls
• Review audit results of the area to ensure corrective and preventive actions are adequate

Required Degree and Experience:

• Bachelor's degree in Engineering, Physical Science, or related discipline
• 2+ years' Manufacturing Quality experience with a medical device company

Required Skills and Knowledge:

• Minimum of 3 years' experience with process validation, risk management, nonconformance handling and process improvement in accordance with CFR 820.30 (FDA QSR) and/or ISO 13485.
• Experience working with class III medical devices
• Working knowledge of ISO 13485, 14971 and FDA CFR 820 and similar global standards
• Thorough understanding of process controls, risk management, statistics, test method validation, and new product development processes
• Knowledge of product and process verification and validation
• Experience writing documents for review by regulatory agencies
• Good knowledge of statistics, DOE's, process capability calculations
• Ability to work as part of a cross functional team
• Ability to define, organize, and manage individual and team tasks
• Effective verbal and written communication
• Proficient in technical report writing and review
• Structured and methodical problem-solving approach
• Foster a positive culture of growth, collaboration, and achievement across the organization Strong oral and written communication skills and ability to interact effectively with all functions within the organization

Preferred Skills and Knowledge:

• Master's degree in Engineering with 1-3 years' Manufacturing Quality experience in a medical device company
• Working knowledge of ISO 5840
• Experience with valve manufacturing or biological tissue product
• Membership on the American Society of Quality Control (ASQ) or Society of Reliability
• Experience with JAMA Connect requirements management software
• Strong knowledge of inspection methods in design, fabrication, and production of mechanical components. Demonstrated skill in using test and measuring equipment
• Solid analytical and problem-solving skills, such as six sigma, and statistical applications experience
• Proven organizational and leadership skills with the ability to work under pressure in a fast-paced environment
• Professional certifications such as, ASQ CQE, Six Sigma or CQA

What We Offer:

• 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.

Health and Wellness Offerings:

• 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