We are seeking an experienced Sr. Software Process Engineer with experience in the medical device industry, or another highly regulated field.
Key skillset needed: 5+ years of experience as a Software and/or Software Process Engineer in the Medical Device industry, specifically using IEC 62304 Testing Standards.
About the role:
- We are seeking a highly motivated R&D Software Process Engineer. The successful candidate will participate in the design and development of medical device software.
- Be a part of an R&D team to develop innovative products that sustain and improve the lives of patients around the world. You will use your technical and collaboration skills alongside your passion for innovation and continuous improvement to drive growth through efficient and effective development of new products.
Your responsibilities include:
- Leads the on-going sustaining and software update cadence for the global footprint of intravascular imaging systems.
- Represents the software function with cross-functional project team members.
- Works cross-functionally to coordinate, develop, and communicate project schedules and refine project scope.
- Drives completion of software team deliverables based on regulations and Quality System requirements.
- Participates in reviews of design, code and documentation.
- Authors and maintains documentation of software development activities according to the Quality System.
- Tracks software development effort by creating and maintaining records in the approved software version control system.
- Investigates, researches, and selects software designs, operating systems, tools and practices.
- Interacts with senior internal and external personnel on significant matters requiring coordination between organizations.
- Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes.
- Provides leadership role on championing functional best practices.
- Mentors other engineers in software engineering activities/methodologies and domain knowledge.
- Investigates field complaints and recommends corrective actions
What we are looking for in you:
- 5+ years of experience in Software Development in Medical Device Industry
- Passion for process and ensuring high quality products
- Passion for working on cross functional teams and passion for working with customers
- Degree in Software Engineering, Computer Engineering, Computer Science or Biomedical Engineering
- Experiences with the following:
- Designing and implementing software using C# and WPF
- Windows operating system configuration and management
- Designing and implementing test software and test automation frameworks
- Proven technical leadership
- Knowledge of IEC 62304
Job Type: Full-time
Pay: $95,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- Health insurance
- Health savings account
- Life insurance
- Paid holidays
- Paid time off
Experience level:
Schedule:
Application Question(s):
- How many years of experience in the medical device industry, or another similar field, do you have?
Work Location: In person