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- Lead cross-functional project teams to the successful completion of project goals. Work includes ensuring scope of work, costs, schedules, and risks are properly planned, resourced, and managed.
- Establish design goals and specifications based on requirements and user needs.
- Interact with physicians to transform clinical observations into new device concepts or approaches.
- Monitor progress, provide project updates on a consistent basis and report out and up project progress and status.
- Support the team with all project activities, overview technical challenges, thoroughly analyze problems, identify potential solutions and their ultimate impact on the project and business.
- Design, build and test functional prototypes to demonstrate proof of concept in bench testing and animal studies.
- Manage activities with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services. Must be willing to travel to vendors for various activities.
- Develop and perform design verification and validation activities. Generate test protocols and test reports.
- Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485
- Mentor junior engineers and technicians.
- Able to read, write and understand English.
- Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.
- Self-starter, Productive, highly motivated with "can do" approach.
- Strong interpersonal skills required in the areas of verbal and written communications, customer focus, influencing, and team building.
- Strong listening and assessment skills.
- Strong questioning & problem-solving skills.
Senior R - Westminster, United States - Trisalus Life Sciences, Inc.
Description
Job Description
Job DescriptionDuties and Responsibilities: Lead the design and development of new products from concept to successful market launch through cross functional collaboration and in accordance with FDA and international regulations.
Education & Certifications:
• Minimum of BS in Mechanical, Biomedical Engineering or directly related scientific discipline.
Work Experience:
• Minimum of 8 years' experience in a medical device R&D environment is required.
• Minimum of 1 year of experience in project management.
• Knowledge and/or training of project management, QSR, process development and/or design control processes is a plus.
Knowledge, Skills & Abilities: