Senior Mechanical Engineer
1 day ago
We are seeking a highly skilled Mechanical Engineer to join our team at BridgeMed Solutions Inc. As a key member of our R&D team, you will be responsible for leading and managing engineering projects from concept to prototype and market release, ensuring alignment with regulatory requirements.
Key Responsibilities:
- Lead and manage engineering projects from concept through to prototype and market release, ensuring alignment with regulatory requirements (FDA, ISO).
- Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to develop project plans, schedules, and risk assessments.
- Develop and review technical documentation, including design specifications, test protocols, and validation reports, to support product development and regulatory submissions.
- Oversee the execution of validation activities for new and legacy medical devices, ensuring they meet intended performance and safety standards.
- Facilitate root cause investigations for non-conformance issues, implementing corrective actions and driving continuous improvement initiatives.
Requirements:
- Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field).
- Minimum of 3 years of experience in R&D, medical device industry preferred with a strong understanding of FDA regulations and ISO standards.
- Proven experience in project management and cross-functional team collaboration.
- Strong analytical skills with the ability to conduct detailed assessments and develop effective solutions.
- Excellent communication skills, both written and verbal, with the ability to present complex information clearly to stakeholders.
What We Offer:
- Competitive salary and benefits package.
- Opportunity for professional growth and development.
- Collaborative and dynamic work environment.
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