Yesterday
Public Trust
Unspecified
Unspecified
Engineering - Civil
Marlborough, MA (On-Site/Office)
Description:
Our client is a privately held medical device that innovates in the area of atrial fibrillation. Their focus is dedicated to advancing innovative treatments while creating more accessibility to patients in need. They have recently acquired a world-leading organization and are working on the next generation of a cardiac ablation system. The company is positioned well for rapid growth, while also allowing employees to be a part of a purposeful mission in developing lifesaving technologies.
We're seeking a hands-on, detail-driven Mechanical Engineer to join their fast-paced and collaborative team. This role is part of an exciting next-generation medical device platform and offers a unique blend of mechanical design and documentation ownership-ideal for someone who thrives on both engineering creativity and process precision.
We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $60 - $100 / hr. w2
Responsibilities:
• Act as technical support for engineering teams, contributing to the design and development of components, subsystems and systems.
• Create design documentation to support medical device product development in alignment with regulatory requirements and industry standards.
• Collaborate with cross-functional teams, including R&D, clinical, and regulatory, to review documentation and specifications to ensure alignment with user needs and product goals.
• Develop test plans, procedures, and protocols for verification testing, ensuring that components meet design specifications.
• Use CAD and other software tools to communicate and define designs.
• Ensure all design and development activities adhere to regulatory requirements (e.g., FDA, CE, MDR), and maintain detailed, accurate documentation throughout the product lifecycle.
Experience Requirements:
Education Requirements:
• Bachelor's degree in Mechanical Engineering or a related field
Our client is a privately held medical device that innovates in the area of atrial fibrillation. Their focus is dedicated to advancing innovative treatments while creating more accessibility to patients in need. They have recently acquired a world-leading organization and are working on the next generation of a cardiac ablation system. The company is positioned well for rapid growth, while also allowing employees to be a part of a purposeful mission in developing lifesaving technologies.
We're seeking a hands-on, detail-driven Mechanical Engineer to join their fast-paced and collaborative team. This role is part of an exciting next-generation medical device platform and offers a unique blend of mechanical design and documentation ownership-ideal for someone who thrives on both engineering creativity and process precision.
We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $60 - $100 / hr. w2
Responsibilities:
• Act as technical support for engineering teams, contributing to the design and development of components, subsystems and systems.
• Create design documentation to support medical device product development in alignment with regulatory requirements and industry standards.
• Collaborate with cross-functional teams, including R&D, clinical, and regulatory, to review documentation and specifications to ensure alignment with user needs and product goals.
• Develop test plans, procedures, and protocols for verification testing, ensuring that components meet design specifications.
• Use CAD and other software tools to communicate and define designs.
• Ensure all design and development activities adhere to regulatory requirements (e.g., FDA, CE, MDR), and maintain detailed, accurate documentation throughout the product lifecycle.
Experience Requirements:
- Bachelor's degree in an Engineering related field
- 3+ years of experience in the medical device industry required .
- Experience with development lifecycles , including requirements gathering, design, development, testing, and integration.
- Knowledge of medical device regulations (e.g., FDA, ISO 13485, IEC 62304) and design control processes.
- Strong understanding of CAD and modeling tools .
- Experience collaborating with global teams to execute on time and on budget.
Education Requirements:
• Bachelor's degree in Mechanical Engineering or a related field
group id: 10106647
