Future Opportunities - Join Our Talent Pipeline for R&D Device Engineer – Mechanical, Electrical, or Software Engineer

Role Summary

The Device Engineer will work collaboratively with a team to design and develop medical products from initial concept through the transfer to production. The engineer will have a technical leadership role for designing and testing components and subassemblies of the overall system product. Skills for thermal or structural analysis as well as statistical analysis are needed. He or she develops a thorough understanding of design requirements to ensure that the system’s objectives are properly defined and ultimately achieved.

Responsibilities

• Act as a technical lead for product development projects. Provide mentoring and guidance to other team members.
• Manage the overall development of parts and subassemblies for a project design. Interact with Clinical and Marketing departments to determine design requirements and goals.
• Outline and execute to short-term goals to achieve overall project milestones.
• Conceive, design, build, and evaluate prototypes to explore a range of design concepts.
• Prepare, present, and document designs at technical reviews.
• Refine and develop selected concept(s) with little guidance from manager.
• Investigate and evaluate materials, adhesives, and assembly techniques based product requirements and based on past experience.
• Select vendors for prototypes, request quotes and prepare purchase requisitions. Provide recommendations for production vendors.
• Use best methods of design for manufacture and assembly (DFMA) and document the DFMA benefits of the chosen design.
• Plan, perform, and document verification testing. Coordinate testing by other team members,
• Help develop assembly procedures and assist in transfer methods to manufacturing.
• Document ECO changes within the Document Control system.
• Coordinate design tasks for other team members for complex product designs.
• Coordinate design constraints within ME team and other R&D groups. Resolve any design conflicts with preferably no managerial intervention.

Qualifications

• BS in Mechanical, Software, Electrical Engineering or equivalent degree. Advanced degree desirable.
• Must have at least eight years of product design and development experience; prefer ten years of experience.
• Prefer at least three years of experience in medical devices, ideally class II devices.
• Individual will complete work with minimal supervision of the manager. Will typically be the technical leader.
• Proficient with basic standard concepts and constraints involved in creating new product designs. Should be knowledgeable of new modern methods for making prototype or production parts.
• Ability to set medium term project goals and outline schedules for multiple tasks for several team members.
• Strong team player with the demonstrated abilities and willingness to wear ‚Äúmultiple hats‚Äù and perform a wide range of tasks within a dynamic environment.
• Individual must have strong verbal and written communication skills.

Additional Requirements

• Responsible for performing all duties in compliance with FDA‚Äôs Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.