This Innovation Staff Engineer position serves as the Technical Design Lead for new product development projects and programs, leading the design and development of various medical products, and identifying and evaluating new medical device product technologies for future development and commercialization. This position is also accountable to ensure all applicable design deliverables are complete and accurate in compliance with new product development process requirements.
Roles and Responsibilities
- Develop and execute new product development plans ranging from technology readiness through commercialization. Ensure plans align with cross-functional development team.
- Interact with customers and clinicians by discussing complex medical conditions to foster an innovative and interactive dialog and feedback on new product development or current projects. Evaluates new medical device technologies for potential development and commercialization opportunities.
- Lead projects by integrating all aspects of design work from all new product development partners (both internal and external), to include engineers, technical writers, scientists, and technicians. Ensure that technical output of assigned projects meets quality, design, and user need requirements.
- Creates and maintains the technical schedule for assigned projects using appropriate tools including Gantt Charts, Network Logic Diagrams, Work Breakdown Structure, and/or other tools as needed. Obtains input from technical team, consolidates schedule information, and drives consensus amongst technical team. Regularly communicates schedule plan and status to management and technical team to ensure successful completion of project.
- Manages assigned project resources, company team members well as suppliers, to meet project schedules. Works effectively with research and development team members as well as team members across the organization to include but not limited to engineering, scientists, legal, manufacturing, quality, medical and regulatory.
- Familiar with rapid prototyping techniques to turn concepts into design for customer feedback and review.
- Prepare and present written project status updates to functional management, project managers, and the project technical team. Project status updates shall include status on performance to schedule and budget, project risks, and technical progress.
- Ensures intellectual property related to assigned projects is identified and documented.
- Ensures project activities are consistent with the product development and design control process. Drives maintenance and completion of project deliverables required by the product development process and as approved by the new product development governance committee.
- Requires a Bachelor Degree in Engineering such as Mechanical, Electrical, Biomedical, General Engineering, or equivalent.
- Requires 9-13 years with a Bachelors Degree or (7-11) with a Masters experience in product development within a cross functional development environment.
- Significant development experience in regulated design environments - specifically medical device development, Food and Drug Administration (FDA) or International Organization for Standardization (ISO) registered work experience.
- Ability to deal effectively with all employees and external business contacts while conveying a positive, service oriented attitude.
- Ability to communicate effectively, both verbally and in writing.
- Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.
- Experience in various Manufacturing Processes for commercial products
- Experience in Embedded Systems Development
- Project management training and experience
- Experience in a startup company (medical device company preferred)
- Experienced in using Solidworks