Job Description
Job Description
Main Responsibilities :
- Architect, Design, implement and evaluate mechanical engineering designs which meet defined product requirements and design goals while being highly manufacturable, reliable and optimum cost for the business.
- Responsible for decision making and documentation based on engineering analysis / testing through excellent analytical and communication (verbal and written) skills.
- Responsible to Develop, Design and implement test methodologies that support characterization and verification of product requirements and design specifications.
- Collaborate with Vendor, Process Development and Quality for manufacturability (DFM), manufacturing test development and resolution of production issues or field complaints.
- Conduct all activities and deliverables following all applicable internal procedures based on applicable medical device regulatory requirements for design and manufacturing, including medical device materials, processes, and GMP (Good Manufacturing Practices).
- Develops high level project plans and provides feedback on development strategy, development cost, product cost, project risks, and timelines for each project.
- Assess project level needs (including resourcing) and manage them to completion; communicate project status, present proposals and recommendations to mitigate project concerns to functional / program management.
- Mentor colleagues and / or direct work of other more junior level engineers.
- This role will be an onsite role with the expectation of being at the location at least 3 days a week on average.
Educational Requirements :
Bachelor of Science in Mechanical Engineering.
Master of Science in Mechanical Engineering / PhD in technical field would be a plus.
Work Experience :
- 15+ years of experience in mechanical engineering design, w ith at least 3+ years of regulated industry experience.
- Proven skills in understanding customer needs for diagnostic medical devices or wearable medical devices, or implanted medical devices in a regulated environment.
- Good knowledge of tools such as SolidWorks, and familiarity with other mechanical engineering tools.
- Familiarity with design process and documentation needs to meet regulatory requirements would be a plus.
- Experience in managing projects from inception to post-market sustaining.
- Familiarity with Class II or Class III medical products would be helpful.
- Have a significant background in mechanical engineering for electronic devices to help proactively identify dependencies between mechanical and electrical requirements of the program.
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