Senior Mechanical Engineer
1 month 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 Senior Mechanical Engineer provides mechanical engineering leadership with developing and commercializing a medical device system. This position will lead and be responsible for the mechanical design, development and testing for the tissue components of a transcatheter aortic valve system for treatment of aortic stenosis. This person will work with other engineers and contract manufacturers to achieve project milestones and product functionality. This position requires strong technical skills and independence in the design and development of a new class of transcatheter heart valve. Key Responsibilities: Play a primary technical role in mechanical design, test, and documentation to meet compliance and product requirements and satisfy customer needs of a medical delivery system. Design, prototype and develop novel design solutions for catheter-based products to improve performance and ease of use in clinical procedures. Work independently as well as with the functional and project teams to develop technical solutions to complex problems that require ingenuity and creativity. Lead troubleshooting and problem-solving efforts related to mechanical design of Delivery System. Supports and communicates decisions through thorough engineering practices and data analysis. Create and communicate design/test plans, tasks, deliverables, and status. Manage time and resources to meet committed schedule milestones. Participate in or lead the definition of product/design requirements, mechanical development, design and implementation of mechanical components and the documentation and release of designs. Follow documented design processes to meet regulatory and company requirements. Responsibilities include generating engineering documentation for a design control process in a regulated environment. Interface with vendors, manufacturing, and other internal groups. Maintain Design Control activities for new product development from initial concept through commercialization. These activities may include the following: developing product specifications, performing robust design evaluation, creating risk analyses, meeting goals for design reviews, and setting & executing design verification and validation strategies. Work with suppliers to ensure components meet design requirements and diagnose design problems. Perform design transfer from R&D to manufacturing. Socially inclusive to the unique needs of a global team and Anteris’ AORTIC Values. Required Skills and Knowledge: Associate’s degree in Mechanical Engineering, Physical Science, or related discipline required. Bachelor’s degree strongly preferred. Minimum of 10 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience. Knowledge of standards and directives such as ISO 5840, ISO 10555. Prior experience developing Class III medical devices. Task planning, sub-team management and leadership skills and experience. Experience with 3D modeling software, i.e. SolidWorks and/or Creo. Experience designing and developing mechanical assemblies. Experience with Design Verification planning, testing, and reports. Ability to manage multiple tasks and projects. Experience creating technical, written content. Demonstrated data analysis skills. Ability to interpret technical drawings and creating Bill of Materials. Demonstrated written and verbal communication skills. Strong understanding of mechanical engineering principles and methodologies. Experience in product design and development in an R&D environment. Ability to use structural finite elements software such as Cosmos or Ansys. Experience in plastic part design and injection molding. Working knowledge of Microsoft Office tools. Communication, presentation, technical writing, and organizational skills. Familiarity with systems engineering principles. Experience using statistical analysis software to prepare test data for regulatory review (e.g. Minitab, MedStat). Experience with component qualifications, including using external manufacturers to build custom components. Experience in management of test equipment calibration. Preferred Skills and Knowledge: Knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards. Familiarity with manufacturing processes, quality assurance, reliability assurance, clinical, risk management. Experience with Early Feasibility testing and submissions. 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. #J-18808-Ljbffr
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