Sr. Mechanical Design Engineer - MFG Equipment

Sr. Mechanical Design Engineer - MFG Equipment

Design and construct manufacturing equipment used to produce minimally invasive medical devices. This equipment will range in complexity from custom manual fixtures to semi-automated electro-mechanical systems, integrating work-holding, sensing, motion and vision control. This position will play a critical role in developing cutting edge manufacturing capabilities to enable the future of minimally invasive surgery.

The ideal candidate should have a solid understanding of the technical aspects of mechanical engineering and design. He/she will work closely with manufacturing and product design engineers to develop and sustain custom equipment for production use.

Primary Roles & Responsibilities:

• Design and build in-house manufacturing equipment from concept to implementation.
• Create effective design solutions of mechanical assemblies from simple fixturing to more complex assembly and fixtures for automation equipment.
• Iterate rapidly by prototyping, testing, and examining product designs using engineering methods and techniques, including computer simulation and physical models
• Create and manage project plans including schedules, budgets, and stakeholder updates.
• Develop documentation for equipment including specifications, assembly instructions, maintenance, and calibration procedures.
• Conduct effective design reviews of new equipment at all stages of development.
• Provide equipment-related technical support for on-going production operation and expansion.
• Establish and manage external resources (contractors, system integrators, vendors) in the planning and execution of equipment projects including duplication activities.

Additional Roles & Responsibilities:

• Ensure manufacturing equipment designs meet functional, safety, ergonomic, and documentation requirements, to facilitate efficient production operations.
• Create and execute protocol documentation for equipment DQ, IQ, OQ, PQ validations.
• Provide controls-related root-cause analysis and technical support to on-going production operations.
• Support other equipment-related operations and duties as required

Skill/

Job Requirements:

• B.S. in Mechanical Engineering or similar; advanced degree preferred.
• Minimum 8 years' experience designing and developing Automated manufacturing equipment.
• Proficiency with CAD (Solid Works highly preferred): designing parts with complex geometry, creating assemblies and creating detailed manufacturing drawings
• Comfortable operating machine shop, measurement, and test equipment
• Mechanical design and exploration skills, including statics, dynamics, and strength of materials, including stress analysis, fatigue, and thermal analysis.
• Experience in integration of mechatronics components such as sensors, motors, pneumatics, and motion and vision control components.
• Experience in working with precision parts, locating features, machine tolerances
• Familiarity with pneumatic controls, sensors, vision systems, servos and other actuators.
• Excellent understanding of tolerance analysis and statistical methods. Fluency in ASME Y14.5 GD&T and tolerance stack analysis
• Prior Experience developing equipment qualification, calibration and PM procedures and practices.
• Prior Experience with enterprise software (e.g. Agile document control, Confluence, Polarion, Windchill, etc)
• Prior experience working with PLM systems (Agile preferred), SAP applications, including ECO creation, origination of equipment specification, test protocols, BOM, and work instructions.
• Great attitude, eager, willing/able to take initiative, works well with others in team environment.
• Ability to travel nationally and internationally. Travel requirements will be approximately 5%.