Manufacturing Engineer, Delivery System

Reports to: Director of Operations

Workplace Type: Onsite

Capstan Medical: Creating a new standard for minimally invasive structural heart treatment

Key Responsibilities:

• Support and optimize manufacturing processes for the current generation delivery catheter system, including assembly, bonding, gluing, laser welding, and testing.
• Lead equipment selection, tooling development, and fixture design to enable efficient and repeatable production.
• Create and maintain manufacturing documentation, including work instructions, process flow diagrams, PFMEAs, and validation protocols (IQ/OQ/PQ).
• Execute and support process validation activities to ensure compliance with FDA and ISO 13485 requirements.
• Drive root cause investigations and implement CAPAs to support continuous improvement and nonconformance resolution.
• Support pilot builds, clinical manufacturing, and scaling to commercial production.
• Participate in design reviews, DFM/DFA discussions, and risk assessments.
• Contribute to the selection and management of external suppliers, contract manufacturers, and test labs.

Skills:

• Process Development & Optimization – Ability to design, document, and refine scalable manufacturing processes for medical devices.
• Validation Expertise – Skilled in writing and executing IQ/OQ/PQ protocols for equipment and processes.
• CAD & Engineering Tools – Proficient in tools like SolidWorks or AutoCAD 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 engineering change orders (ECOs).
• Problem-Solving – Resourceful and proactive in identifying, analyzing, and resolving manufacturing issues.

What you’ll need:

• 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; heart valve or Class III device experience strongly preferred.
• Hands-on experience with cleanroom assembly, micro-assembly, and/or biological material handling is a plus.
• Working knowledge of GMP, FDA regulations (21 CFR Part 820), and ISO 13485.
• Experience with validation (IQ/OQ/PQ), risk management (FMEA), and statistical tools (Minitab, JMP).
• Strong problem-solving skills, attention to detail, and the ability to manage multiple priorities.
• Excellent written and verbal communication skills.

Why Join Us:

• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off
• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.