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

Role Summary

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

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 “multiple hats” 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’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements.