We are looking for someone that will support the Design and development of new Implantable Neurological products.
Activities include product design and development, technical management, personnel management, methods/process development, design modeling, tooling design/fabrication, equipment design/fabrication, design verification and validation, and documentation.
This position will lead development projects as part of a multi-functional project team and will report directly to the VP of Product Development.
The role has overall responsibility for project planning, scheduling, and assigning work direction to team members. This individual will lead efforts for product design and testing assuring compliance with the company’s QMS and applicable regulatory requirements, lead the execution of clinical builds and participate in manufacturing transfer to operations.
- Interface directly with customers to ensure their needs are being met.
- Document program progress and all critical decisions made during project meetings.
- Design and implement new prototypes and products based on customer specifications.
- Develop product requirements and specifications based on customer needs and applicable guidelines (industrial and government guidelines and/or standards).
- Specify and develop test methods to determine the acceptability of designs to requirements.
- Perform data analysis (statistical and practical) and develop appropriate action plans.
- Develop tooling and fixturing for product assembly and testing.
- Support pre-clinical testing.
- Serve as a technical resource to other departments as needed.
- Follow company policies and procedures.
- Serve as a mentor for less-experienced engineers.
- Perform other duties as assigned to support company objectives.
Education, Experience and Other Skills
- Bachelor’s degree or higher in an engineering/scientific field and/or 10-year medical device industry experience with a focus on Product Development.
- Proficient with MS Office software.
- Must be able to work using a microscope.
- Must have good hand dexterity and the ability to manipulate small components and tools.
- Must be able to lift and carry items up to 20lbs.
- Must be willing to work in lab, machine shop, and clean room environments to support project work.
- Must have excellent time management skills.
- Must be willing to travel occasionally (10%) to support customer projects or company objectives.