Principal Implant Engineer - Glaucoma
Orange County Metro Area, CA
- Responsible for execution of technical deliverables on a variety of development projects within Surgical Glaucoma R&D. This includes functioning as highly collaborative team member and technical contributor, and, at times, providing guidance and leadership to teams.
- Serves core team as technical lead, defines project plans and ensures technical deliverables are delivered on time and within the scope of product development plan guidelines.
- Creates and maintains the design control documentation through the product development process.
- Gathers, understands, and analyses requirements from stakeholders for the development of medical devices while supporting existing products and service infrastructure.
- Synthesizes all gathered information together with technical and regulatory constraints in order to define a system and its behavior resulting in defining a product/system specification.
- Performs technical planning and performance evaluation studies, conducts technology assessment activities, analyses system integration issues, generates initial baseline interface specification, estimates costs and risk, and evaluates human factors through testing, analysis and studies.
- Designs utilizing Solid works/Pro Engineer design software, directly and by providing direction to design engineering support teams.
- Defines and conducts all verification and validation activities.
- Assures that new intellectual property is disclosed and that patent filings are fully supported.
- Engages and communicates effectively and transparently with all stakeholders.
- The ability to fluently read, write, understand and communicate in English
- Excellent written and verbal English communication skills with superior presentation capabilities required.
- Research and/or product development experience, preferably with ophthalmic implantable medical device focus
- Working knowledge of ISO and FDA regulations
- Demonstrated ability to develop and apply an understanding of clinical techniques to product development
- Extensive experience in root cause analysis, structural reliability testing and analysis of materials for implantable medical products
- FEA, fatigue test method development, test method qualification and validation
- Developing intellectual properties
- CAD system knowledge
- Strong interpersonal, people and process management, and problem solving skills
- Bachelor s degree in Engineering discipline (preferably mechanical) with 10 years relevant experience, advanced degree preferred