SURGICAL INNOVATIONS set the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.
A Day in the Life
Working with collaborative team members, you will perform Quality Engineering functions in support of projects associated with software development, requirement, design, implementation, verification, and failure mode analysis. Work closely with R&D and suppliers to drive to quality improvements and conformance to standards and regulations.
- Ensure the adequacy of software design quality for a Minimally Invasive Surgical System, including documentation and other supporting quality evidence
- Create, review and approve all software development documents associated with each phase of software development, including software verification and validation plans and protocols.
- Participate in software requirement specification development, software design document reviews and code reviews.
- Ability to identify software risks and suggest mitigations by either hardware and/or software modifications. This includes conducting risk analyses and tracking all findings (FMEA, FTA).
- Review and approve software configuration management to verify its practices conform to procedures.
- Document errors and anomalies and assist with corrective and preventative measures. Work closely with other Software Engineers to fix bugs.
- Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control
- Work closely with software engineers
- Participate in Software tool validation and SOUP analysis
- Bachelor of Science Degree in relevant studies, and a minimum of 5 years of relevant experience.
Nice to Have:
- Education Required: BS degree in Engineering, Math, Computer Science, or Equivalent; MS degree in Engineering, Math, Computer Science preferred.
- Minimum 5 years relevant experience; 5 years of experience as a Software Engineer or Software Quality Engineer responsible for software development, testing and/or Software Quality Engineering in a regulated industry (FDA, ISO, etc.).
- Excellent communication skills, both written and oral and must be computer literate.
- Experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO 14971, ISO 13485 requirements.
- Previous software development experience is Desire
- Experience with robotics, controls, dynamics, kinematics, or motion control systems is strongly preferred