The person in this position is responsible for evaluating novel concepts and developing medical products and processes under design control requirements and within the setting of a project team.
Essential Job Function/Duties:
- Work as an interactive member of a team, communicating with leadership to plan, complete and report results of experiments, tests, prototype development, literature surveys, etc. that contribute to projects.
- Gather clinical application information, performance requirements and user needs; perform requirements and risk analyses.
- Remain current with and apply FDA 21CFR820, ISO 13485 and ISO 14971 requirements.
- Design, coordinate and execute design verification and product, process, and method validation activities.
- Assure that project deliverables and tasks are technically excellent and completed in a timely fashion.
- Document deliverables (reports, design documents, manufacturing documents, etc.).
- Ensure that appropriate documentation is kept detailing project history (reports, laboratory notebooks, invention disclosures, scientific literature, meeting notes, etc.)
- Maintain and develop the technical capabilities necessary to provide technical solutions to project needs.
- Understand the intellectual property process; ensure that intellectual property is established, harvested, characterized, and protected.
- Practice continuous improvement by evolving both the quality management system and business processes.
- Conduct other corporate duties when required.
Minimum Work Experience/Educational Requirements:
- MS or PhD in mechanical engineering, electrical engineering, chemical engineering, biomedical engineering or software engineering;
- Knowledge of medical product design control.
- Minimum of three years of industrial or graduate level experience in developing medical products or processes.
- Innovative: Proven ability to generate novel concepts.
- Task Oriented: Demonstrated knowledge and ability to plan, prioritize, coordinate and complete deliverables.
- Collaborative: Ability to effectively communicate and constructively collaborate with colleagues and be a team player.
- Professional: Ability to remain professional and positive in all personal interactions, and provide an example of good work ethic, a willingness to help, and personal discipline in achieving goals.
Sign non-competition and confidentiality agreements. Comply with all policies of the company including without limitation the COOK AT Employee Manual, COOK Group Global Code of Conduct and other Cook Group and Cook AT policies and procedures. Authorized to work in the USA without visa support.