Senior Product Development Engineer, Medical Device
About the Company:
EyeCool Therapeutics is a pioneering medical technology company at the forefront of developing innovative solutions for ocular health. Our commitment to advancing cutting-edge therapies stems from a passion for improving the lives of individuals affected by eye-related conditions. With a focus on precision and efficacy, EyeCool Therapeutics is dedicated to bringing transformative treatments to the field of ophthalmology.
Join Our Team:
At EyeCool Therapeutics, we believe that exceptional talent drives our success. As a part of EyeCool, you will have the opportunity to contribute to groundbreaking advancements in ocular therapeutics and make a meaningful impact on patients' lives.
The Position:
We are actively searching for a Senior Product Development Engineer with specific experience in Medical Device design and development. The successful candidate will be an integral part of the product development team and will drive different aspects of development from concept to commercialization. This person will collaborate with a multidisciplinary team of experts to contribute to the development and implementation of our groundbreaking therapies. If you are passionate about pushing the boundaries of medical device technology and are eager to be part of a company dedicated to revolutionizing eye care, we encourage you to apply.
Qualifications:
· Bachelor’s degree in mechanical or biomedical engineering (or related discipline) required
· Minimum of five (5) years relevant engineering experience in a regulated industry required
· Proficient in SolidWorks, Microsoft Office (Word, PowerPoint, Excel, Outlook, etc.)
· Working knowledge of medical device Design Controls and Risk Management (FMEAs)
· Experience in project management, good documentation practices, and a working knowledge of quality systems and medical device regulations (ISO 13485, 21 CFR 820)
· Familiarity with Geometric Dimensioning and Tolerancing (GD&T)
· Experience with Human Factors Engineering and Usability is a plus
· Ability to work independently and clearly communicate issues, risks, and risk mitigation plans to project stakeholders
· Strong interpersonal skills and ability to collaborate as part of a cohesive team
· Self-starter with strong work ethic, organizational skills, and attention to detail
Responsibilities:
· Conceiving and developing innovative products and advancing them through the product lifecycle
· This position will be exposed to all aspects of the product development process, including solid modeling (SolidWorks preferred), drawing generation (SolidWorks), prototyping, engineering analyses, manufacturing transfer, Verification and Validation testing, design reviews, and clinical/commercial product readiness
· Developing 3D models and 2D drawings in SolidWorks for product designs, assembly fixtures, and auxiliary equipment leveraging design experience and best practices
· Designing and developing test methods and protocols for Design Verification
· Performing Risk Management activities, including dFMEA and pFMEA generation
Additional Expectations:
· The Senior Product Development engineer will work with the project team to appropriately plan, de-risk, and execute projects
· This position is expected to be primarily on-site and requires a significant amount of hands-on work (prototyping and 3D printing, testing and test development, team interfacing, etc.)
Job Type: Full-time
Pay: $95,000.00 - $115,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
Schedule:
Ability to Commute:
- Cambridge, MA 02138 (Required)
Ability to Relocate:
- Cambridge, MA 02138: Relocate before starting work (Required)
Work Location: In person