Job description
Responsibilities:
- Our unique setting of integrated Strategic Innovations and New Product Development provides an exceptional opportunity to R&D engineers to be involved in end-to-end product development from a user centric front-end innovation process via rigorous product development to market launch.
- As a R&D Engineer located in Danbury, CT, you will have the opportunity to take a hands-on technical leadership role to drive product development activities ranging from disposable surgical devices, complex thermo-fluidic systems and electro-mechanical diagnostic instruments to sophisticated IVF laboratory workstations and systems involving IT connectivity, machine learning and AI.
- Responsibilities
- Work closely with our commercial and clinical teams as well as key opinion leaders, clinicians, and users to create, devise and develop solutions, concepts and improvements which will enable future innovations and drive new products and line extensions.
- Create adequate design inputs (product requirements) and outputs (design specifications), define technical strategies for an effective verification and validation approaches and drive development of corresponding test methods and fixtures.
- Develop and design products and product improvements including components and assemblies, of electro-mechanical systems using engineering best practices and leveraging first principles, analytical modeling, CAD, GD&T and DFSS tools.
- Manage R&D workstreams including projects with external partners, engineering consulting firms and OEMs.
- Drive design control compliance by ensuring that all applicable safety, quality and regulatory guidelines and policies for are followed to develop safe and effective medical devices.
- Assess technologies and intellectual properties of competitive products/and or acquisition targets in support of business growth strategies.
- Requirements
- Expertise in CAD modeling (SolidWorks preferred), mechanical design and creation of engineering drawings including GD&T required.
- Medical device development experience with thorough understanding of design control guidelines including verification and validation methods required.
- Proficiency with engineering first principles and analytical methods including structural and fluid mechanics required.
- Advance understanding of Design for Manufacturing (DFM) required.
- Understanding of statistical methods including design of experiments required.
- Ability to plan activities and lead technical teams or work independently with minimal direction required.
- Hands-on craft skills and experience with building, fixing, servicing and/or fabricating concepts, fixtures, prototypes or similar required.
- Experience with translating customer to product requirements, conducting harm-based risk analysis and defining acceptance criteria preferred.
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