Sr. Engineer, Design Dev, R&D
About The Position
The Senior R&D Engineer plays a high impact role from concept to launch of innovative surgical products while leading project core teams through Design History File generation and commercialization activities. As a technical leader, the Sr. R&D engineer will work with project management and a cross-functional project core team to appropriately plan, de-risk, and execute projects. The ability to work in a cross-functional environment and gather needed information from other functions are critical skills to be successful in this position. The ideal candidate will be internally motivated and personally accountable to project success. They will be excited by the opportunity to develop world class solutions for known User challenges and unmet needs. They will also enjoy learning from and teaching others in the department to strengthen oneself and continue to improve the abilities of others on the team. It is expected that the candidate will have strong mechanical design expertise, with the ability to create production-ready assemblies and fully defined drawings.
Requirements
- Bachelor’s degree in Engineering or related discipline required, Mechanical/Biomedical (mechanical) Engineering preferred
- Minimum of eight (8) years relevant engineering experience in a regulated industry required, medical device experience strongly preferred.
- Experience designing components within a medical device facility utilizing CAD software preferred
- Proficiency with Solidworks required.
- Familiarity with various materials and processes, such as extrusion processing, injection molding, machining operations, fixture and tooling development, and adhesive and thermal bonding techniques
- Experience in project management, documentation, and a working knowledge of quality systems and medical device regulations (ISO13485).
- Working knowledge and application of ASME Y14.5-2009 Dimensioning and Tolerancing for Engineering Drawings.
- Self-starter with strong proactive work ethic, well-organized and detail-oriented.
Responsibilities
- Project planning, requirements development, test planning and execution to generate auditable Design History Files.
- Cross-functional technical leadership to facilitate development activities and honor timelines and budgets as projects advance through the product development process.
- Generating detailed designs for surgical product concepts in an organized and consistent manner
- Developing models and drawings in SolidWorks for product designs, assembly fixtures, and auxiliary equipment leveraging design experience and department design standards and best practices.
- Developing product assembly documentation as required.
- Mentor peers and junior engineers and contribute to the culture of growth and development.
- Support project managers and facilitate project success through project scoping, planning, risk mitigation, team building and execution management activities.
- Apply design for manufacturing principals to component and device design.
- Initiate and own document changes for drawings and other controlled documentation.
- Create and release documentation for purchase and assembly of equipment.
- Determines cost of equipment, parts, and tooling related to designed equipment.
- Assists in the preparation of capital purchase requests.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
