Staff Clinical Engineer

VDyne, Inc.; Osseo (MN); Sur place; USD 120 000 - 150 000; Plein temps

Avantages offerts par ce poste

Medical, dental and vision insurance

HSA with employer contribution

401(k) with company match

Paid time off

Paid holidays

Life and disability insurance

Professional development support

Résumé du poste

VDYNE, Inc. is seeking a Staff Clinical Engineer to lead advanced clinical engineering programs, shape therapy direction, and mentor junior engineers.

You’ll serve as the technical backbone connecting clinical data to product decisions and participate in cross-functional design reviews across R&D and therapy development. The role emphasizes high autonomy, independent program leadership, and input into device iteration and product requirements, with collaboration across clinical and leadership

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field; advanced degree preferred
• 8+ years of experience in clinical engineering for Class III medical devices
• Advanced proficiency with segmentation and anatomical modeling tools (e.g., 3Mensio, 3Matic, Radiant)
• Advanced proficiency with statistical analysis software (e.g., Minitab, JMP, MATLAB)
• Advanced proficiency with design software (e.g., SolidWorks, Fusion 360)
• Demonstrated ability to lead complex technical programs independently and drive findings to strategic recommendations
• Experience with Good Documentation Practices (GDP) and functioning 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

Responsabilités

• Lead anatomical analysis including CT segmentation and measurement; develop workflow
• Lead physical modeling of patient anatomy using SolidWorks, 3D printing, and related tools
• Independently design and execute statistical analysis of anatomy, bench, and clinical data; develop analytical frameworks
• Lead evaluation of case imaging including fluoroscopy and echocardiography
• Lead root cause investigation and analysis of case outcomes; drive actionable conclusions
• Own development of protocols and reports; lead in-vitro and in-vivo testing programs
• Serve as a primary contributor to therapy direction, device iteration, and product requirements
• Lead patient screening workflow optimization and algorithmic modeling for patient selection
• Provide technical mentorship to Clinical Engineers and Sr. Clinical Engineers
• Represent the clinical engineering function in cross-functional design reviews and external engagements

Connaissances

Leadership

Mentoring

Cross-functional collaboration

Communication skills

Problem solving

Formation

Bachelor’s degree in Mechanical or Biomedical Engineering

Advanced degree preferred

Outils

3Mensio

3Matic

Radiant

Minitab

JMP

MATLAB

SolidWorks

Fusion 360

Description du poste

WHY VDYNE

VDYNE is a clinical-stage medical device company focused on developing innovative transcatheter valve solutions for tricuspid regurgitation (TR), a life-threatening condition. With its patented side-delivery technology, VDYNE enables minimally invasive procedures, expanding treatment options for TR patients. Headquartered in Minneapolis, Minnesota, VDYNE is actively conducting clinical studies across the United States, Europe, and Australia. The company's mission is to transform patient outcomes through groundbreaking advancements in medical technology. This position will be instrumental in helping VDYNE achieve these ambitious goals.

THE ROLE

The Staff Clinical Engineer is a senior technical authority within VDYNE’s R&D and Therapy Development function. This is a high-autonomy, high-impact role — you’ll independently lead complex clinical engineering programs, shape therapy direction, and serve as the cross-functional technical backbone connecting clinical data to product decisions. You’ll also be a key mentor to Clinical and Sr. Clinical Engineers on the team.

What You'll Do

• Lead anatomical analysis including complex CT segmentation and pre/post-implant measurement; drive methodology development and workflow optimization


• Lead physical modeling of patient anatomy using SolidWorks, 3D printing, and related tools


• Independently design and execute statistical analysis of anatomy, bench, and clinical data; develop analytical frameworks for team-wide use


• Lead evaluation of case imaging including fluoroscopy and echocardiography


• Lead root cause investigation and analysis of case outcomes — positive and unanticipated — and drive findings to actionable conclusions


• Own development of protocols and reports; lead in-vitro and in-vivo testing programs


• Serve as a primary contributor to therapy direction, device iteration, and product requirements as an output of clinical analysis


• Lead patient screening workflow optimization and algorithmic modeling for patient selection


• Provide technical mentorship and guidance to Clinical Engineers and Sr. Clinical Engineers


• Represent the clinical engineering function in cross-functional design reviews, strategy discussions, and external clinical engagements

WHAT WE'RE LOOKING FOR

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field; advanced degree preferred


• 8+ years of experience in clinical engineering for Class III medical devices


• Advanced proficiency with segmentation and anatomical modeling tools (e.g., 3Mensio, 3Matic, Radiant)


• Advanced proficiency with statistical analysis software (e.g., Minitab, JMP, MATLAB)


• Advanced proficiency with design software (e.g., SolidWorks, Fusion 360)


• Demonstrated ability to lead complex technical programs independently and drive findings to strategic recommendations


• Experience with Good Documentation Practices (GDP) and functioning 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

Preferred

• 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

What Makes This Role Different

At most companies, clinical engineering is a support function. At VDYNE, the clinical engineering team is a core strategic driver — your analytical work directly shapes how our device evolves and how we select and treat patients. As Staff, you’ll have the autonomy to build analytical frameworks, lead cross‑functional initiatives, and influence therapy direction at the highest level. You’ll also be mentoring the next generation of clinical engineers on a team that genuinely values technical depth.

Compensation & Benefits

VDYNE offers a competitive compensation package including base salary commensurate with experience, annual performance bonus, and equity participation.

• medical, dental, and vision insurance


• HSA with employer contribution


• 401(k) with company match


• paid time off


• paid holidays


• life and disability insurance


• and professional development support

In accordance with Minnesota pay transparency requirements, the anticipated salary range for this role is $120,000 – $150,000 annually, depending on experience and qualifications.

VDYNE, Inc. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable law.