Job Description:
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The Senior R&D Engineer II plays a pivotal role in managing and delivering research and development activities associated with the lifecycle management of products for treating acute ischemic stroke. This position involves overseeing various aspects of the product lifecycle, including material changes, process improvements, regulatory submissions, shelf-life studies, responding to sales and marketing requests, and investigating returned products.
Key Responsibilities:
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* Acquire in-depth knowledge of current products from a technical perspective, encompassing design, materials, performance, and manufacturing processes.
* Lead product/process optimization projects in collaboration with Supply Chain and Quality teams.
* Support second supplier and/or technical transfer projects.
* Manage project sub-parts as part of a larger project team.
* Provide direction to other team members, including mentoring and oversight of less experienced engineers or technicians.
* Support regulatory submissions and lead Design Verification/Validation studies as required by regional authorities.
* Conduct product Shelf-Life studies through Design Verification testing.
* Investigate product complaints and analyze returned devices.
* Support CAPA and Non-Conformance processes.
* Evaluate and scope process changes, material changes, vendor changes.
Required Skills and Qualifications:
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* Strong technical background with expertise in product design, materials science, and manufacturing processes.
* Excellent communication and leadership skills, with ability to mentor and direct team members.
* Proven track record of successfully managing projects and leading cross-functional teams.
* Ability to analyze complex technical data and make informed decisions.
* Strong problem-solving skills, with ability to investigate and resolve issues efficiently.
* Excellent organizational and time management skills, with ability to prioritize tasks effectively.
Benefits:
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This exciting opportunity offers a chance to grow your career with a reputable Medical Device organization, providing a dynamic and challenging work environment. The role includes excellent salary, bonus, pension, healthcare, and opportunities for professional growth and development.
Others:
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This is a fantastic opportunity for a talented R&D professional to join our organization and contribute to the success of our Medical Devices. If you are passionate about innovation, technology, and delivering exceptional results, we encourage you to apply for this position.