Principal Mechanical Engineer
3 weeks ago
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 Principal Mechanical Engineer will be responsible for the mechanical design, development, and testing of a transcatheter heart valve and related accessory components for the treatment of aortic stenosis. This person will work with other engineers and contract manufacturers to achieve project milestones including, but not limited to, design verification testing, regulatory submission and product launch of initial concepts and future iterations of the product.
This position requires strong technical skills and independence to advance the design and development of the world's most durable transcatheter heart valve and delivery system. This individual is expected to serve as a technical lead for the transcatheter heart valve team to complete the development and commercialization of a novel medical device system.
Key Responsibilities:
Plays primary technical role as a team lead in mechanical design, test, and documentation to meet compliance and product requirements and satisfy customer needs for a transcatheter heart valve.
Works independently as well as with the functional and project teams to develop technical solutions to complex problems that require ingenuity and creativity.
Leads troubleshooting and problem-solving efforts related to mechanical design of implantable and / or external instruments and associated systems.
Supports and communicates decisions through thorough engineering practices and data analysis.
Creates and communicates design/test plans, tasks, deliverables, and status. Manages time and resources to meet committed schedule milestones.
Participates or leads in the definition of product /design requirements, mechanical development, design and implementation of mechanical components and the documentation and release of designs.
Follows documented design processes to meet regulatory and company requirements. Responsibilities include generating engineering documentation for a design control process in a regulated environment.
Works with suppliers to ensure components meet design requirements & diagnose design problems.
Performs design transfer from R&D to manufacturing.
Interfaces with vendors, manufacturing, and other internal groups.
Required Degree and Experience:
Bachelor's degree in mechanical engineering; Master's degree preferred.
Minimum of 10 years' related experience.
Experience developing structural heart products.
Required Skills and Knowledge:
Experience developing Class III structural heart medical devices.
Strong understanding of mechanical engineering principles and methodologies.
Experience in product design and development in an R&D environment.
Task planning, sub-team management and leadership skills and experience.
Communication, presentation, technical writing, and organizational skills
Experience giving advice and mentoring or consulting other engineers.
Experience with Design Verification planning, testing, and reporting.
Experience creating technical, written content.
Knowledge of standards and directives such as ISO 5840.
Knowledge of FDA Quality System Regulations, Medical Device Directives including ISO 13485, ISO 14971, and ISO 62304 standards.
Experience 3D modeling software, i.e., SolidWorks and/or Creo.
Ability to use structural finite element analysis software such as Cosmos or Ansys.
Demonstrate data analysis skills and sound statistical analysis methodologies to prepare data for regulatory review (Minitab, JMP or MedStat).
Experience with generating test data to support Early Feasibility, testing and submissions.
Ability to interpret technical drawings and create a Bill of Materials.
Demonstrate strong written and verbal communication skills.
Working knowledge of Microsoft Office tools
Preferred Skills and Knowledge:
Strong understanding of mechanical properties of biocompatible materials.
Familiarity with cardiac anatomy and physiology.
Familiarity with manufacturing processes, quality assurance, reliability assurance, clinical, risk management.
Familiarity with systems engineering principles.
Experience with component qualifications, including using external manufacturers to build custom components.
Experience in management of test equipment calibration.
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
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