Senior Mechanical Engineer - Medical Device

Stark Pharma Solutions Inc; Burlington (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Stark Pharma Solutions Inc in Burlington, MA seeks a Senior Mechanical Engineer to join Heart Failure R&D, focusing on Mechanical Circulatory Support devices. You will design, develop, and validate components for life-sustaining medical devices and drive projects from concept to commercialization.

The role requires hands-on CAD, FEA/CFD, and robust knowledge of materials and manufacturing processes. You will collaborate across disciplines and mentor junior engineers while ensuring regulatory

Qualifications

• Bachelor's degree in Mechanical Engineering or a related field.
• 6+ years of mechanical design and product development experience, preferably in medical devices.
• Hands-on testing experience using INSTRON or similar equipment.
• Strong CAD design experience with engineering drawings and GD&T.
• Experience supporting medical device product development projects.

Responsibilities

• Design, develop, verify, and validate mechanical components for implantable cardiovascular devices.
• Lead product development from concept through commercialization while ensuring regulatory compliance.
• Develop and execute mechanical test methods using INSTRON or similar systems.
• Create CAD models, drawings, and GD&T documentation using SolidWorks.
• Perform analyses (FEA/CFD) to optimize performance and reliability.
• Lead design reviews and prepare technical documentation and specifications.
• Collaborate with Systems, Electrical, Software, Clinical, Manufacturing, and Quality teams.
• Support prototype development, supplier interactions, and component sourcing.
• Mentor junior engineers and contribute to technical excellence.

Skills

Mechanical design

GD&T

Engineering drawing

FEA/CFD

Product development

Regulatory compliance

Education

Bachelor's degree in Mechanical Engineering

Tools

INSTRON testing

SolidWorks

Job description

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: [e-mail]

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com