Anteris Technologies · 9 hours ago
Senior Mechanical Engineer - Valve Team
Maple Grove, MN
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expAnteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care. The Senior Mechanical Engineer will play a key role in the design, development, and testing of a next-generation transcatheter heart valve system and its accessory components, working collaboratively with cross-functional teams throughout the product lifecycle.
BiotechnologyHealth CareMedical
Hiring Manager
Erica Almgren Steffenson
Responsibilities
Serve as a primary technical contributor in the design and development of new products and product improvements
Perform mechanical design, testing, and documentation to meet compliance and product requirements in alignment with customer and regulatory expectations
Work both independently and cross-functionally to develop creative, data-driven technical solutions to complex problems
Lead troubleshooting and root-cause analysis activities related to implantable and/or external instruments and systems
Develop and communicate detailed design and test plans, deliverables, and project status updates
Generate and maintain design control documentation, including procedures, reports, and records, consistent with a regulated environment
Support Quality and Regulatory teams by ensuring design documentation meets applicable standards and company requirements
Interface with vendors and contract manufacturers to ensure component quality, resolve design challenges, and facilitate design transfer
Contribute to design transfer activities from R&D to manufacturing and sustainment engineering
Effectively manage time and resources to achieve project milestones
Qualification
Required
PhD in Mechanical Engineering, Physical Science, or related discipline; or
Master's degree with 2+ years of relevant experience; or
Bachelor's degree with 4+ years of relevant experience; or
8+ years of medical device product design and development experience
Proven experience designing and developing mechanical assemblies, preferably for Class III medical devices
Strong understanding of mechanical engineering principles and methodologies
Proficiency with FEA/CFD tools (Abaqus, Ansys) and 3D CAD software (SolidWorks, Pro/ENGINEER)
Knowledge of ISO 5840 and related medical device design standards
Hands-on experience with Design Verification planning, testing, and reporting
Experience performing statistical analysis and preparing test data for regulatory submission (e.g., Minitab, MedStat)
Ability to interpret engineering drawings, develop Bills of Materials, and create robust documentation
Strong communication, presentation, and technical writing skills
Experience working with external manufacturers and custom component suppliers
Proficiency in Microsoft Office and general engineering documentation tools
Preferred
Familiarity with FDA Quality System Regulations, ISO 13485, ISO 14971, and ISO 62304 standards
Experience with Early Feasibility testing and submissions
Knowledge of cardiac anatomy and physiology
Understanding of systems engineering principles and design transfer processes
Exposure to manufacturing, quality assurance, and risk management
Demonstrated ability to plan tasks, lead sub-teams, and manage technical priorities
Benefits
Medical, Dental, and Vision Offerings
Healthcare & Flexible Spending Account (HSA / FSA)
401k + Company Match
Life, AD&D, Short Term and Long-Term Disability Insurance
Bonus Plan Eligibility
Employee Equity Program
Paid Holidays & Vacation
Employee Assistance Program
Inclusive Team Environment
Company
Anteris Technologies
Anteris Technologies is a structural heart company focused on developing innovative & durable health solutions.
51-200 employees
H1B Sponsorship
Anteris Technologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
Funding
Current Stage
Public CompanyTotal Funding
$34.29MKey Investors
Partners for Growth
2023-02-09Post Ipo Equity· $24.29M
2017-10-01Post Ipo Debt· $10M
2004-03-24IPO
Leadership Team
Wayne Paterson
CEO and Managing Director
David St. Denis
Chief Operating Officer
Recent News
Anteris Technologies Pty Ltd
2025-11-18
Anteris Technologies Pty Ltd
2025-11-13
MarketScreener
2025-11-03
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