Versa Vascular is an innovative medical device startup developing next-generation implantable solutions for the treatment of tricuspid heart valve disease. Our mission is to improve patient outcomes through precision engineering, rigorous quality standards, and collaborative innovation.

We are seeking a highly motivated Manufacturing Engineer to support the development of a next-generation heart valve implant and delivery system. This role will serve as a key technical contributor responsible for bridging product development and manufacturing, ensuring robust, scalable, and compliant manufacturing processes throughout the product lifecycle.

The Manufacturing Engineer will work closely with cross-functional teams including Research & Development, Quality, Regulatory, Supply Chain, and Production to drive process development, technology transfer, manufacturing readiness, and continuous improvement initiatives. This individual will provide hands-on production support, lead root cause investigations, implement corrective and preventive actions, and help solve complex manufacturing challenges in a fast-paced startup environment.

The ideal candidate is a proactive problem solver who thrives in a dynamic setting, possesses strong technical and analytical skills, and is passionate about bringing innovative medical technologies to patients.

Skills:

• Process Development & Optimization – Ability to design, document, and refine scalable manufacturing processes for medical devices.
• Validation Expertise – Ability to write and execute IQ/OQ/PQ protocols for equipment and processes.
• CAD & Engineering Tools – Proficient in tools like SolidWorks for fixture/tooling design.
• Root Cause Analysis – Experience with 5 Whys, Fishbone Diagrams, and other RCA methods.
• Assembly Techniques – Familiarity with precision assembly, especially under a microscope, and bio-compatible material handling.
• Fixture & Equipment Design – Ability to design and troubleshoot jigs, fixtures, and semi automated equipment.
• Document Control – Ability to work within a QMS and manage document change notices (DCNs).
• Problem-Solving – Resourceful and proactive in identifying, analyzing, and resolving manufacturing issues.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related field.
• 2+ years of experience in a medical device or regulated manufacturing environment is strongly preferred.
• Hands-on experience with cleanroom assembly, micro-assembly, and/or biological material handling is a plus.
• Working knowledge or ability to learn GMP, FDA regulations (21 CFR Part 820), and ISO 13485.
• Experience with validation (IQ/OQ/PQ), risk management (FMEA), and statistical tools (Minitab, JMP) is a plus.
• Strong problem-solving skills, attention to detail, and the ability to manage multiple priorities.
• Excellent written and verbal communication skills.

Skills

• Knowledge of metrology, dimensional measurement, and inspection techniques.
• Proficiency with measurement instruments, microscopes, and testing fixtures.
• Strong attention to detail, organizational skills, and ability to work independently.
• Effective written and verbal communication skills in English.
• Proficiency with Microsoft Office applications.

Why Join Versa Vascular

• Help bring innovative structural heart therapies to patients with significant unmet clinical needs.
• Work alongside a highly experienced team of clinical, engineering, and cardiovascular experts.
• Influence clinical strategy and execution at a critical stage of company growth.
• Competitive compensation, equity participation, and comprehensive benefits.
• Collaborative culture that values innovation, ownership, and professional development.
• Opportunity to make a meaningful impact on the future of cardiovascular care.

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