Senior Mechanical Engineer - Medical Device

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Sr Mechanical Engineer position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Role: Senior Mechanical Engineer Heart Failure R&D

Location: Burlington, MA

Contract Duration: 12 Months

Position Overview

We are seeking a Senior Mechanical Engineer to join an innovative Heart Failure R&D team focused on the development of next-generation Mechanical Circulatory Support (MCS) devices, including Left Ventricular Assist Devices (LVADs). This role offers the opportunity to contribute to the design, development, testing, and commercialization of life-sustaining Class III medical devices.

The ideal candidate will bring strong product development experience, expertise in mechanical design and testing, and a passion for advancing cutting-edge cardiovascular technologies.

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.
  
  

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com