Technical Design Lead
This Product Development Engineer position assumes the role of Technical Design Lead for various medical product design and development projects. The Technical Design Lead is responsible for completing all activities related to product design and development while collaborating with other product development core team members. This position is accountable for ensuring the timely and successful launch of the product as well as the accurate completion of applicable deliverables required by the product development process.
Roles and Responsibilities
- Depending on the type and scope of project, this position works independently or leads engineering teams on new product development projects, integrating all aspects of design work. Engineering teams can include one or more engineers (mechanical, electrical and software) to complete the design and development of products. Position requires that technical output of assigned projects meet 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, Acelity employees as well as suppliers to Acelity, in order 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.
- 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.
- Develops budgets for assigned projects. Manages project expenses to ensure adherence to budget. Provides regular updates to functional management and project managers on project expense status.
- Ensures project activities are consistent with the Acelity product development and design control process. Drives maintenance and completion of project deliverables required by the Acelity product development process and as approved by the new product development governance committee.
- A Bachelor Degree in Engineering such as Mechanical, Biomedical, or equivalent.
- A minimum of 5 years of experience in product development. Experience to include technical project management and experience with commercial products.
- Some project management 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.
- Licensed Professional Engineer
- Medical product design and development experience.
- Project Management training and certification as well as three years applicable project management experience.
- Experience in Manufacturing Processes for commercial products.