Staff Mechanical Engineer

Job Summary The Staff Mechanical Engineer is responsible for the mechanical design and development of life-saving medical devices. This includes definition, design, implementation, debug, test, and post-production support in a regulated environment. Additional responsibilities include development and maintenance of design documentation, participation in technical reviews, work planning and estimation, and providing technical support to other internal cross-functional groups. May also support research, design, and technical feasibility projects. This position requires the candidate to possess a high level of creativity and apply knowledge of engineering principles. Essential Functions

• Employs the appropriate level of engineering rigor to mechanical designs ensuring product robustness, reliability, and patient safety.
• Designs plastic injection molded parts with an understanding of best practices, material selection, tooling, and troubleshooting.
• Utilize 3D Computer Aided Design (CAD) software with an understanding of advanced modeling techniques.
• Employs CAE simulation software to verify design element(s) including but not limited to FEA, CFD, and mold flow.
• Designs electro-mechanical assemblies and mechanisms.
• Creates 2D engineering drawings per

ASME Y14.5

standards.

• Generates and processes Engineering Change Orders.
• Conducts tolerance analysis of mechanical assemblies.
• Supports design reviews with a high level of scrutiny and thoroughness.
• Designs body worn mechanical enclosures for EMI/RF containment and environmental constraints, specifically ingress protection (IP66/67).
• Consults with Human Factors and implements usability and preference attributes to mechanical designs including soft goods and garments.
• Defines, plans, and executes project related deliverables while effectively communicating to the appropriate stakeholders within the organization.
• Supports advanced development technical feasibility studies for future generation products.
• Conducts product failure investigations, root cause analysis, and Design of Experiments (DOE) process for sustaining engineering activities.
• Supports Supplier Quality Engineering (SQE) with Medical Process Validation activities.
• Researches new products, tools, components, technologies and processes; develops and demonstrates prototypes and recommends a course of action.
• Works closely with Project Management to plan and track project status.
• Coaches mechanical co-ops while effectively delegating project tasks.
• Uses interpersonal skills to coordinate with internal and external teams effectively. Required/Preferred Education and Experience
• Bachelor's Degree in Mechanical Engineering or related engineering field strongly preferred.
• In lieu of a Bachelor's Degree, an Associate Degree in Mechanical Engineering Technology or a related technical field with significant industry experience (typically 10+ years) will be considered.
• A minimum of 8 years of mechanical engineering or related field is required. Knowledge, Skills and Abilities
• Understanding and practical working knowledge of various manufacturing processes and fabrication methods (e.g. machining, casting, sheet metal, adhesives) and their associated limitations, benefits and tradeoffs.
• Proficient utilizing PLM/PDM (Windchill preferred).
• Proficient utilizing SolidWorks and/or Creo.
• Understanding and practical working knowledge of Finite Element Analysis (FEA) software (ANSYS preferred).
• Medical Device or regulated industry experience preferred.
• Body-worn (wearable) electronic design for textiles and soft goods a plus.
• General experience with Microsoft Office (Word, Excel, etc.).
• Must have excellent communication skills, both verbal and written.
• Fundamental understanding and experience applying Geometric Dimensioning and Tolerancing (GD&T) preferred.
• Six Sigma Green Belt Certification preferred.
• Experience with project management and technical leadership (preferred). Travel Requirements
• Occasional travel may be required.

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