Staff Clinical Engineer

VDyne•Maple Grove, MN

12d•$120,000 - $150,000

About The Position

The Staff Clinical Engineer is a senior technical authority within VDYNE’s R&D and Therapy Development function. This high-autonomy, high-impact role independently leads complex clinical engineering programs, shapes therapy direction, and connects clinical data to product decisions. The role also provides mentorship to Clinical Engineers and Senior Clinical Engineers. The Staff Clinical Engineer leads anatomical analysis and modeling, statistical analysis, imaging evaluation, and investigations of case outcomes. The position owns protocols and reports, leads in-vitro and in-vivo testing programs, contributes to therapy direction and product requirements, and optimizes patient screening and selection workflows. The role represents clinical engineering in cross-functional design reviews, strategy discussions, and external clinical engagements. VDYNE describes clinical engineering as a core strategic driver: analytical work directly shapes device evolution and patient selection and treatment. The role offers the autonomy to build analytical frameworks, lead cross-functional initiatives, and influence therapy direction. Compensation includes a base salary commensurate with experience, an annual performance bonus, and equity participation. The anticipated salary range is $120,000–$150,000 annually, depending on experience and qualifications.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
At least 8 years of experience in clinical engineering for Class III medical devices.
Advanced proficiency with segmentation and anatomical modeling tools, such as 3Mensio, 3Matic, or Radiant.
Advanced proficiency with statistical analysis software, such as Minitab, JMP, or MATLAB.
Advanced proficiency with design software, such as SolidWorks or Fusion 360.
Demonstrated ability to independently lead complex technical programs and drive findings to strategic recommendations.
Experience with Good Documentation Practices (GDP) and working within quality systems.
Ability to mentor and develop engineers at multiple levels.
Strong written and verbal communication skills, including presenting to cross-functional and leadership audiences.

Nice To Haves

Advanced degree.
Structural heart experience, particularly in valve therapies.
Experience with algorithmic modeling or patient-selection workflow development.
Advanced familiarity with fluoroscopy and echocardiographic imaging.
Experience contributing to therapy strategy or product roadmap discussions.

Responsibilities

Lead anatomical analysis, including complex CT segmentation and pre- and post-implant measurement; develop methodologies and optimize workflows.
Lead physical modeling of patient anatomy using SolidWorks, 3D printing, and related tools.
Independently design and execute statistical analyses of anatomical, bench, and clinical data and develop analytical frameworks for team-wide use.
Lead evaluation of case imaging, including fluoroscopy and echocardiography.
Lead root cause investigations and analysis of positive and unanticipated case outcomes, and turn findings into actionable conclusions.
Own protocol and report development and lead in-vitro and in-vivo testing programs.
Contribute to therapy direction, device iteration, and product requirements based on clinical analysis.
Lead patient-screening workflow optimization and algorithmic modeling for patient selection.
Mentor and guide Clinical Engineers and Senior Clinical Engineers.
Represent clinical engineering in cross-functional design reviews, strategy discussions, and external clinical engagements.