Senior Mechanical Engineer

Our client is a leading medical device company dedicated to revolutionizing healthcare through innovative technologies. Their mission is to improve patient outcomes by developing cutting-edge medical devices that set new standards in the industry. Located north of Boston, their dynamic team is committed to driving advancements in healthcare through creativity, collaboration, and a passion for excellence.

They are seeking a highly skilled and motivated Senior Mechanical Engineer to join their dynamic team. As a Senior Mechanical Engineer, you will play a crucial role in the design, development, and optimization of their next-generation medical devices. This is an exciting opportunity to contribute to groundbreaking projects that have the potential to make a significant impact on the healthcare industry.

Key Responsibilities:

1. Product Design and Development:

   • Lead and contribute to the design and development of complex mechanical systems and components for medical devices.
   • Utilize CAD software to create detailed 3D models, drawings, and prototypes.

2. Technical Leadership:

   • Provide technical leadership in mechanical engineering, guiding and mentoring junior engineers.
   • Collaborate with cross-functional teams, including electrical engineers, software engineers, and industrial designers, to ensure seamless integration of mechanical components.

3. Design Optimization:

   • Conduct analysis and simulations to optimize designs for performance, reliability, and manufacturability.
   • Implement design changes based on feedback from prototype testing and validation.

4. Regulatory Compliance:

   • Work closely with the regulatory affairs team to ensure designs comply with relevant industry standards and regulations.
   • Contribute to documentation for regulatory submissions.

5. Collaboration and Communication:

   • Communicate effectively with internal teams and external partners to ensure alignment on project goals and timelines.
   • Participate in design reviews and provide constructive feedback to enhance overall product quality.

6. Prototyping and Testing:

   • Oversee the fabrication and testing of prototypes, conducting root cause analysis and implementing design improvements as needed.
   • Collaborate with the testing and validation team to ensure products meet performance and safety requirements.

Qualifications:

• Bachelor's degree in Mechanical Engineering or a related field; Master's degree preferred.
• 5+ years of experience in mechanical engineering, with a focus on medical device design.
• Proficiency in CAD software (SolidWorks, Pro/ENGINEER, etc.).
• Strong understanding of materials, manufacturing processes, and design for manufacturability.
• Experience with design verification, validation, and testing processes.
• Familiarity with regulatory requirements for medical devices (FDA, ISO, etc.).
• Excellent problem-solving skills and a proactive approach to overcoming engineering challenges.