Job description

Client 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, US; Geneva, Switzerland; Brisbane, and Perth Australia.

We are adding a new Senior Mechanical Engineer to our R&D team! The Senior Mechanical Engineer will provide engineering leadership & expertise in the development and commercialization of our TAVR medical device. This position will be responsible for the mechanical design, tissue development, engineering characterization, component testing, and the overall THV performance for the treatment of aortic stenosis. This senior engineer will work with other engineering functions and contract manufacturers to achieve project milestones and product functionality. With strong technical skills and engineering independence, the Senior Mechanical Engineer will play a significant impact in the design and development of the world’s most durable transcatheter heart valve. Join us!
About The Job

• Plays primary technical role in mechanical design, test, and documentation to meet compliance and product requirements and satisfy customer needs of a medical device system.
• Interface with external vendors and partners on key development activities and milestones.
• 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 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 milestones.
• Contributes to the development of engineering capabilities for future development and product characterization of valves.
• 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
• External facing communication with contractors and physicians where applicable
• Follows documented design processes to meet regulatory and company requirements
• Responsibilities include generating engineering documentation in a regulated environment
• Create and release design control documentation, written procedures, and reports
• Work with suppliers to ensure components meet design requirements & diagnose design problems
• Performs design transfer from R&D to manufacturing
• Application of DFMA principals to process development milestones
• Globally inclusive to the AORTIC values: Accountability, Objectivity, Respect, Teamwork and Courage

About Your Experience And Qualifications

Required Degree and Experience:

• Bachelor’s degree in Mechanical Engineering, BioMedical Engineering, Physical Science, or related discipline
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years relevant experience

Preferred Degree and Experience:

• MS in Mechanical Engineering with a minimum of 5 years engineering experience
• Knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards

Required Skills and Knowledge:

• Knowledge of standards and directives such as ISO 5840
• Tissue engineering & characterization
• 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 ProEngineer
• Experience designing and developing mechanical assemblies
• Experience with writing FDA tests and submissions
• Experience with Design Verification planning, testing, and reports
• Ability to manage multiple tasks and projects
• Expert at 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
• Working knowledge of Microsoft Office tools
• Communication, presentation, technical writing and organizational skills
• Familiarity with systems engineering principles
• Familiarity with manufacturing processes, quality assurance, reliability assurance, clinical, risk management

Preferred Skills and Knowledge:

• Ability to use structural finite elements software such as Cosmos or Ansys
• Experience in plastic part design and injection molding
• Experience using statistical analysis software to prepare test data for regulatory review (e.g. Minitab)
• Experience with component qualifications, including using external manufacturers to build custom components
• THV development experience

Our health and wellness offerings

• Medical Offering
• Dental Offering
• Vision Offering
• 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
• Paid Vacation
• Paid Parental Leave
• Employee Assistance Program
• Inclusive Team Environment

Job Type: Full-time

Salary: $65,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Hastings, NE 68901: Reliably commute or planning to relocate before starting work (Required)

License/Certification:

• Driver's License (Preferred)

Work Location: One location

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