- Design and develop new products and product improvements.
- Assist with Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) projects to support valve frame design and testing.
- Coordinate design, testing and documentation activities to ensure on schedule project deliverables.
- Work within a cross-functional team and provides oversight of third-party vendors and service providers such as design firms and test laboratories.
- Collaborate with Marketing, Medical Affairs, Regulatory and others to document user and product requirements.
- Design, document, and implement production methods and fixtures to support new products or product improvements.
- Design experiments (DOE) and analyze data to present to regulatory bodies.
- Support various Quality and Regulatory activities such as audits, preventative and corrective actions, etc.
- Perform root cause analysis of design issues to ensure adherence to the Quality Management System.
- Bachelor's degree in Engineering, Physical Science, or related discipline. Master's degree preferred.
- Experience designing and developing mechanical assemblies.
- Demonstrate aptitude working with FEA/CFD software packages (Abaqus or Ansys).
- Experience using 3D modeling software, i.e. SolidWorks.
- Ability to manage multiple tasks and projects.
- Demonstrate written and verbal communication skills.
- Demonstrate data analysis skills and experience using statistical software (Minitab preferred).
- Strong understanding of mechanical engineering principles and methodologies.
- Experience creating technical, written content.
- Working knowledge of Microsoft Office suite.
- Experience in product design and development in an R&D environment working on Class III devices.
- Experience with Design Verification planning, testing and reports.
- Knowledge of standards and directives such as ISO 5840.
- Ability to interpret technical drawings and creating a Bill of Materials.
- Experience with regulatory submissions.
- Familiarity with manufacturing processes, quality assurance, reliability assurance, clinical, and risk management.
- 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
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Mechanical Engineer I - Maple Grove, United States - Anteris Technologies Ltd
3 weeks ago
Description
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 Mechanical Engineer will apply their knowledge of physics, engineering, simulation engineering and biomechanical standards to the design, development, and component and assembly level testing of a transcatheter aortic valve system for treatment of aortic stenosis. This person will work with other engineers to research, design and evaluate new product development initiatives as well as execute continuous improvement processes for existing concepts.
This position requires strong technical skills and independence in the design and development of a new class of transcatheter heart valve.
Primary Duties and Responsibilities:
