Senior Research and Development Engineer, Systems
Share
Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Department:
Job Summary
Overview
This role is responsible for ensuring the overall functionality safety and efficacy of medical devices. Manages the design development and integration of firmware software hardware electronics and disposables.
Responsibilities
- Develop system architectures and specifications including: defining user requirements design inputs software requirements feature descriptions and
user stories. - Conduct risk management activities including risk analysis for system software and cybersecurity.
- Lead systems integration efforts across various engineering disciplines.
- Ensures compliance with relevant industry standards including but not limited to ISO 13485 IEC 60601 IEC 62304 and ISO 14971.
- Ability to effectively work and communicate in technical cross-functional teams to develop new products.
- Continuously improves process and work methodologies by interfacing with peers/crossfunctional groups and analyzing activities to improve work processes.
Qualifications
Required Qualifications:
- BS Degree in Biomedical/Electrical Systems/Software Engineering or related field; Masters preferred
- Minimum of 5 years of experience analyzing system requirements design and testing
- Software integration and black box testing methodologies
- Experience with multi-tasking real-time operating system
- Agile development experience
- Strong working knowledge of IEC 60601 IEC 62304 ISO 13485 and ISO 14971
- Experience and understanding of Design Controls and SDLC
Preferred Qualifications:
- Familiarity with best practices of software development for medical devices
- Strong Project Management skills
- Familiarity with Agile GitHub and Azure Dev Ops
Physical Requirements:
- Works under general office environmental conditions
- Sitting for extended periods utilizes close visual acuity for working with computers etc.
- Ability to travel 25% of the time
Required Experience:
Senior IC
Key Skills
- Administration And Accounting
- ABAP
- BPO
- Art And Craft
- Employee Benefits
- ACCA
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
