Mechanical Design Engineer

The Mechanical Design Engineer's responsibility is to work with customers to design components and assemblies for use in the medical device industry, as well as assist in process development and validation/qualification activities. The Mechanical Design Engineer is also responsible for designing mold tooling and production fixtures, as well as planning and documenting initial product builds to meet customer and regulatory requirements.

Essential Functions

• Provide engineering feasibility and propose concepts to customers during the product development stage.
• Design and review injection-molded / over-molded components, mechanical assemblies, and interconnects for the medical device industry.
• Work with team members to ensure specification compliance of designs and system performance through design verification and qualification.
• Hands-on development of processes and creation of manufacturing documentation.
• Coordinate mold tooling and fixture design/manufacturing.
• Participate in part/assembly design reviews, as well as tooling design reviews, both internally and externally with suppliers and customers.
• Use engineering changes to develop, review, and release required documentation within ClearPath Medical's QMS framework.
• Initiate and manage prototype/engineering builds for use in pre-qualification and verification activities.
• Identify the root cause of problems found, develop solutions, and implement changes to address issues as they arise.
• Meet and understand all program timing requirements. Become familiar with Gannt charts as a tool to meet all project deliverables.
• Set up equipment such as molding machines, wire/cable cutting and stripping machines, and other cable assembly processing tools.
• Work from schematics, customer specifications, diagrams, written and verbal descriptions.
• Seek opportunities to improve processes. This may include areas such as project management, design, and assembly methods. Coordinate with internal resources to propose solutions and support implementation.
• Follow all employee guidelines and Quality System requirements as defined by ClearPath Medical's practices, policies, and Standard Operating Procedures to ensure customer and FDA requirements are met.
• Perform other duties as assigned.
• Must comply with all safety requirements.

Required Education

• Required: Bachelor's degree and experience (2+ years) in a relevant medical device manufacturing industry.

Required Skills

• Proficient in 2D and 3D CAD (Solidworks, AutoCAD, etc.)
• A firm understanding of engineering principles as applied to part, assembly, and tooling design
• Highly organized, detail-oriented, and able to multitask.
• Ability to work independently.
• Makes and fulfills commitments; meets deadlines and accepts responsibility for their actions.
• Adjust quickly and effectively to changing conditions and demands.
• Good comprehension of Manufacturing/Enterprise Resource Planning systems.
• Proficient in MS Office: Word, Excel, Outlook
• Develop a firm understanding of the project development process, associated terminology, and quality system requirements.
• Excellent attendance and a positive attitude.
• Good written and oral communication skills; must have the ability to communicate effectively and project a professional image when giving and taking information in writing and in person.