This position will lead development projects as part of a multi-functional project team through the design and development of new, and perform modifications to existing products. Activities may 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.
Manage product development programs with minimal oversight.
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.
Communicate program progress and critical decisions to company management.
Design and implement new 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 tests for product testing determining acceptability of designs to requirements.
Perform data analysis (statistical and practical) and develop appropriate action plans based upon such analysis.
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.
Identify opportunities for productivity and quality improvements.
Education, Experience and Other Skills
Bachelor’s degree or equivalent in an engineering field and medical device industry experience with a focus on Structural Heart Device and/or Delivery System Product Development.
Proficient with MS Office software or similar (i.e. word processing, spreadsheets, project scheduling, etc)
Mental and Physical Requirements
Must have good hand dexterity and the ability to manipulate small components and tools.
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 to support customer projects or company objectives.
Authority and Responsibility
Accountable for personal performance.
Accountable for controlling project budget.
Authority to delegate project related work to project team members and accountable to inform management if individuals are not completing work as required by project schedule.