Senior Mechanical Engineer - Medical Device

Key Responsibilities

• Design, develop, verify, and validate mechanical components and subsystems for implantable cardiovascular medical devices.
• Lead product development activities from concept through commercialization while ensuring compliance with regulatory and quality requirements.
• Develop and execute mechanical test methods using INSTRON or similar compression/tension testing systems.
• Create detailed CAD models, engineering drawings, and GD&T documentation using SolidWorks or equivalent CAD tools.
• Perform engineering analyses including FEA, CFD, and simulation studies to optimize product performance, reliability, and manufacturability.
• Conduct design verification and validation testing, risk assessments, and technical investigations.
• Lead design reviews and prepare technical documentation, specifications, reports, and engineering records.
• Collaborate with Systems, Electrical, Software, Clinical, Manufacturing, and Quality teams throughout product development.
• Support prototype development, supplier interactions, and component sourcing activities.
• Mentor junior engineers and contribute to technical excellence across the organization.

Required Qualifications

• Bachelor's degree in Mechanical Engineering or a related engineering discipline.
• 6+ years of experience in mechanical design and product development, preferably within the medical device industry.
• Hands-on experience developing and executing test methods using INSTRON or similar mechanical testing equipment.
• Strong CAD design experience, including engineering drawings and GD&T.
• Proven experience supporting medical device product development projects.
• Proficiency with SolidWorks or equivalent CAD software.
• Experience with engineering analysis tools such as FEA and simulation software.
• Strong understanding of materials, manufacturing processes, and design for reliability.
• Excellent technical communication and documentation skills.

Pay

N/A

Schedule

N/A

Benefits

N/A

Contact

To apply, please send your updated resume to karthik@starkpharma.com.