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Senior Mechanical Design Engineer
2 months ago
At Intellectt Inc, we are seeking a highly skilled Senior Mechanical Design Engineer to join our team. As a key member of our product development team, you will be responsible for designing and developing complex electromechanical systems for Class II/III medical devices.
Key Responsibilities:- Design and Development: Research, design, develop, and test electromechanical devices for VAD and CPB applications.
- Collaboration: Work with cross-functional teams for development of new products, and improvement to existing products driven by corrective and preventative actions (CAPA).
- Requirements and Specifications: Establish requirements (User Needs and Design Input Requirements) and specifications for these products.
- Analysis and Testing: Use experimental, empirical, and numerical analysis to evaluate designs. Develop and qualify (IQ/OQ) fixtures/equipment for verification testing.
- Problem-Solving: Investigate issues and identify root causes in complex systems where analysis of situations or data requires an indepth evaluation of various factors.
- Risk Management: Identify and mitigate both technical risks and program (scope, schedule, budget) risks.
- Documentation: Create/review technical drawings for appropriate assembly, dimensioning, and tolerancing.
- Project Support: Support projects in various capacities: i.e. as an individual contributor, as technical lead of a small team, or a subject-matter expert/consultant.
- Regulatory Compliance: Provide input and support to Regulatory Affairs for FDA/global regulatory submissions.
- Vendor Evaluation: Aid in vendor evaluations such as manufacturing capability and capacity, engineering support, and quality controls.
- Quality Management: Complies with FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Education: B.S. in Mechanical, Biomedical, or Manufacturing Engineering.
- Experience: 8+ years engineering experience including product development, process development, risk assessment, and V&V verification related to class II/III medical devices.
- Industry Experience: Industry experience with FDA design controls 21 CFR.
- Communication Skills: Strong communication and presentation skills (e.g. versatility communicating with peers, management, auditors/regulators, and customers).
- Travel: Ability to travel approximately 10%, primarily in the US, but may include international.
