Principal Implant Sys Engineer
•The Principal Engineer – Implant Systems is responsible for the design of systems, subsystems, and/or components for a medical device as part of a new product development team and be involved in all phases of the product development from product concept through commercial launch and sustaining of marketed products.
- The Principal Engineer will support product development efforts as a key member of program teams by leading systems engineering tasks defining, developing and validating a smaller program or several features on a major program.
- Uses broad experience and high technical proficiency to execute projects on a variety of clinical and commercial Surgical Glaucoma procedure and White space applied research topics.
- This will include functioning as team member, technical resources and at times provides direct management to others.
- Gathers, understands, and analyses input requirements from stakeholders for new 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 customer satisfaction through testing, analysis and studies.
- Determine how systems will be architected and implemented.
- Provide guidance and leadership to teams as appropriate.
- Model and detail implant and instrument design utilizing Solid works/Pro Engineer design software.
- Manage the design control creation through the new product development process. Work with project head to and oversee technical teams to ensure project plans adhere to agreed upon timelines and are within the scope of product development plan guidelines.
- Provide guidance in conducting and evaluating Verification and validation activities so they comply with internal standard, exploit all technical standard and are statistically relevant.
- Assures that new intellectual property is disclosed through MOI’s and that patent filings are fully supported.
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information
alrpo EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements •Bachelor’s degree in mechanical or bio medical or equivalent engineering field.
- BS + 10 yrs. experience MS + 8-11 yrs. experience Ph.D. + 5-8 yrs. experience
- 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
- Determining product and system specification, cascading requirements from product specification to manufacturing specification, defining CTQ attributes
- Designing, developing, qualifying and launching medical products/technology
- Determining engineering specifications, requirements, building prototypes and products
- Working knowledge of ISO and FDA regulations
- Demonstrated ability to apply expert understanding of clinical application to issues in order to bring tasks to resolution within assigned projects
- Extensive experience in root cause analysis, structural reliability testing and analysis of materials and/or 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
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