Principal Mechanical Engineer

About This Role

Lead technically complex mechanical design efforts for cardiovascular medical devices from concept through manufacturing and product launch, serving as a subject matter expert and mentoring junior engineers.

Responsibilities

• Lead technically complex design efforts from concept through verification and support through transfer to manufacturing, product launch and sustaining
• Act as the recognized subject matter expert in one or more engineering domains (e.g., precision mechanisms, temporary pump technology, fluid-structure interactions, materials and fabrication)
• Translate clinical observations and user needs into validated device concepts and engineering requirements
• Rapidly prototype, test, iterate, and optimize mechanical designs using a variety of fabrication and bench-test techniques
• Perform and lead troubleshooting, incident investigations, and root-cause analysis for design failures or performance issues; develop and implement robust corrective and preventive actions
• Provide formal input to and lead aspects of the design review process; conduct project post-mortem activities and close the loop on improvement opportunities
• Produce clear, rigorous technical documentation including technical reports, technical memoranda, test plans, test reports, design inputs/outputs, and risk analyses
• Present technical findings, project status, and risk trade-offs to R&D management and cross-functional stakeholders
• Mentor, coach, and train junior engineers on engineering methods, tools, manufacturing-feasible design, testing, and problem-solving techniques
• Collaborate effectively with cross-functional teams including Clinical, Regulatory, Quality, Manufacturing, and Suppliers to drive product success

Requirements

• BS in Mechanical Engineering or equivalent
• Minimum 10 years of hands-on product design experience in medical device product development
• Proven track record delivering medical device projects from concept through verification and launch
• Expert proficiency with 3D CAD (SolidWorks preferred) and geometric dimensioning and tolerancing (GD&T)
• Experience in prototyping and fabrication of metal and plastic parts and assemblies
• Strong analytical skills in tolerance stack-up, DFM/DFMEA, FEA or bench-test-driven validation approaches
• Demonstrated experience with root cause analysis tools and methods (8D, 5 Whys, Fishbone, FMEA)
• Excellent written and verbal communication skills
• Experience coaching and mentoring junior engineers
• Ability to work collaboratively in a fast-paced, cross-functional environment

Qualifications

• BS in Mechanical Engineering or equivalent
• Minimum 10 years of hands-on product design experience in medical device product development (or equivalent industry experience)

Nice to Have

• Advanced degree or equivalent in Mechanical Engineering or related field
• Experience with cardiovascular/hemodynamic support devices or other implantable/insertable medical technologies
• Familiarity with medical device regulations and design controls (e.g., FDA, ISO 13485) and risk management per ISO 14971
• Test method development and instrumentation experience (flow rigs, pressure instrumentation, high-speed imaging)
• Experience supporting transfer to manufacturing and supplier development

Skills

* Required skills

Benefits