Senior Mechanical Engineer – Instruments

Senior Mechanical Engineer – Instruments

Requirements

• A passion for solving tough technical problems – solid mechanical intuition and persistence to identify the root cause of a problem, solving problems using first principles.
• Ability to learn rapidly and quickly prototype creative and practical solutions from rough requirements.
• Solid aptitude for experimental design, testing, and data analysis; experience with design of experiments (DoEs) and statistical analysis.
• Ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements.
• Highly proficient using CAD to design and document complex mechanisms and systems; SolidWorks preferred.
• Familiar with all phases of product development lifecycle including design, implementation, debug, verification/validation, qualification, and design transfer.
• Understanding of material and component selection criteria as well as design for reliability and manufacturability best practices.
• Experience with a variety of fabrication methods for metals and plastics, working with suppliers and their processes; including multi-axis machining, MIM, plastic injection molding, overmolding, stamping, extrusions, 3D printing, and laser cutting.
• Experience with medical devices including FDA QSR 21 CFR Part 820, ISO 13485, IEC 60601, and other related external standards.
• Excellent documentation and communication skills.
• Comfortable operating machine shop equipment.
• Minimum BS or MS in Mechanical Engineering, Mechatronics, Biomedical Engineering or related engineering or scientific discipline.
• Minimum 6 years designing mechanical engineering products or relevant experience.

Responsibilities

• Work in a small, cross-functional project team to design and develop robotic surgical instruments.
• Observe clinical cases and participate in interviews with clinical experts to inform designs.
• Document, prepare, and review patent submissions.
• Create and maintain SolidWorks CAD databases, including assemblies, components, and detailed drawings.
• Hands-on design, assembly, and testing of instruments to support proof of concept, design development, pre-clinical, and V&V activities. Support defining and developing technical specifications and requirements for robotic instruments.
• Support the documentation of design and manufacturing processes, including: working with suppliers to create components, inspection procedures, assembly instructions, manufacturing processes, test methods, purchase specifications, bills of materials, component / assembly drawings per the company’s operating procedures.
• Provide support for pre-clinical and clinical labs.
• Generate and execute test methods to characterize designs and to establish root cause of design challenges, manufacturing variation, or material defects. Critically examine test results and make design changes or recommendations to the team.
• Provide written protocols, reports, presentations, and perform technical design reviews to solicit feedback on design activities.
• Provide mechanical engineering support for resolution of field and manufacturing issues.
• Establish individual goals consistent with overall project goals.

Preferred Qualifications

• Experience using SolidWorks, Matlab, and Finite Element Analysis (such as Ansys/ Pro Mechanica)
• Experience with electromechanical design, including cable driven systems and small mechanisms, is preferred.
• Experience and skills in design of high volume (e.g. injection molded, MIM) components, and design for manufacturability strongly preferred
• Medical device design experience
• Experience developing manufacturing processes and assembly instructions