Sr. Mechanical Engineer

Company Description

UnifiMed partners with leading innovators in the MedTech industry, providing specialized support to early-stage founders and executives. As a global advisory firm, we are dedicated to guiding companies through the complexities of commercialization in the U.S. healthcare market. Our team leverages deep industry expertise to help clients navigate challenges, achieve growth, and drive impactful changes. Join us in shaping the future of medical technology innovation via strategic collaboration and guidance.

Role Description

Our client is seeking a Senior Mechanical Engineer to lead the mechanical development and manufacturing readiness of a cardiovascular medical device as it advances through clinical and early commercial execution.

This role is focused on ownership of the mechanical function from design through production. The ideal candidate will ensure that designs are not only technically sound, but manufacturable, scalable, and reliable in real-world use. For the right candidate, this role could be a Principal Mechanical Engineer.

Key Responsibilities:

• Lead mechanical design activities with a focus on manufacturing readiness and production scalability
• Drive design for manufacturing (DFM) and design for assembly (DFA) across all mechanical components and assemblies
• Own tolerance analysis, stack-ups, and design robustness to ensure consistent product performance
• Support and lead design transfer into manufacturing, including process development, build readiness, and supplier coordination
• Identify, troubleshoot, and resolve mechanical issues during builds, validation, and field use
• Collaborate cross-functionally with electrical, firmware, clinical, and regulatory teams to ensure system integration
• Support verification and validation (V&V) activities, including test method development and failure analysis
• Work closely with suppliers and manufacturing partners to optimize quality, cost, and production timelines
• Mentor junior engineers and contribute to building out the mechanical engineering function

Qualifications:

• Bachelor’s or Master’s degree in Mechanical Engineering or related field
• 5 years of experience in medical device or complex electromechanical product development
• Strong experience with DFM/DFA, design transfer, and manufacturing scale-up
• Proficiency in CAD (e.g., SolidWorks or similar) and tolerance analysis
• Experience supporting V&V and working within design control frameworks (ISO 13485, FDA 21 CFR 820)
• Demonstrated ability to troubleshoot and resolve mechanical issues in a production environment
• Experience working with suppliers and contract manufacturers
• Ability to operate in a fast-paced, startup environment with a high degree of ownership

Preferred Qualifications:

• Experience with cardiovascular or implantable medical devices
• Familiarity with materials, fatigue, and durability considerations in regulated environments
• Experience supporting clinical-stage or early commercial products

This is a high-impact role within a lean team, offering the opportunity to take ownership of the mechanical function and play a critical role in bringing a complex medical device into clinical and commercial use.