Senior Design Engineer

Job description

Primary Function of Position Accessories serve as the interface with the da Vinci system and enable safe and effective robotic-assisted surgery. They may be reusable or single-use medical devices (consumables), with yearly volumes in the millions. Our customers interact directly with accessories in every surgical procedure, and they serve a critical role in customer satisfaction and patient outcomes. The Sr. Mechanical Engineer will work on product development of a variety of Accessories.

The successful candidate must excel in a fast-paced team environment and be capable of creative problem solving when faced with the time pressures and design constraints typical of product development. They must have a strong sense of ownership, shared responsibility, commitment to high product quality and be comfortable collaborating across organizational boundaries. Projects will include a mix of product improvements, component enhancements, cost savings and manufacturing improvements to enable significant volume growth.

Essential Job Duties

Provide mechanical engineering sustaining support for resolution of manufacturing and field issues: Characterize sources of variations in product performance and implement mitigations accordingly. Investigate and determine root cause of design, manufacturing, or material issues. Resolve complex engineering challenges through hands-on product testing and collaborate with subject matter experts both internal and external to organization.

Perform complex tolerance stack analyses to evaluate potential failures or performance concerns Design, develop and document components and assemblies for surgical system accessories: Review and understand product functional and design specifications. Create, analyze, and test product designs and their components. Research, understand and design to relevant product specific standards. Develop, implement, test, and document solutions that meet clinical, functional and product requirements.

Designing for manufacturing and automation, sterilization processes and biocompatibility. Provide mechanical engineering expertise to support continuous production of high-quality surgical accessories to our customers: Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of designs into production. Develop components and product mechanical drawings in a regulated environment for high volume manufacturing processes, including plastic injection molding, thermoset compression molding, machining.

Develop Design History Files per FDA requirements. Adept in risk management and design control documentation. Support design for automation such that our product designs can enable technologies that allow volumes to continue to grow year over year. Help establish individual and team goals aligned with overall project and company goals.

Qualifications

Required Skills and Experience

• Minimum
• 8 years of medical product experience (Prior sustaining experience in high volume product preferred)
• Proficiency using CAD to design parts and assemblies and to create specification drawings in a PDM environment; Solidworks strongly preferred.

Experience with complex interface compatibility and tolerance analysis Strong working knowledge of GD&T Ability to communicate effectively and accurately (written and oral) across all levels and functions, including presenting to a technical audience. Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements. A passion for solving tough technical problems - Strong mechanical intuition and persistence to drill down to pinpoint root cause of problems, solving problems using fundamental principles.

Required Education and Training B.S. Mechanical or Biomedical Engineer (or equivalent) required, MS preferred. Working Conditions Ability to Travel up to 10%

Preferred Skills and Experience

Proven experience with design for assembly, manufacturing, and automation. Experience working on products with volumes in the 10’s of millions is preferred. Demonstrated knowledge of materials (preferably plastics, silicones, polyurethanes, isoprenes) and material properties. Ability to apply knowledge of engineering materials and component selection criteria to product designs through strong concept development, design analysis, hands-on prototyping, and reliability testing skills.

Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer. Comfortable with concepts of design input, design output, traceability, and risk analysis