System Design Engineer
Job description
Title: System Engineer / System Design Engineer / Design History File
Location: Remote
Qualifications:
- DHF experience is a must (entire scope is DHF documentation, testing, and remediation)
- Experience as a system designer (or similar) role (ideally 5 years, would consider less)
- Strong communicator (proactive, organized)
- SaMD is "nice to have," not mandatory — design controls familiarity matters most
- Codebeamer not required (any DHF software okay)
- Comfortable drafting requirements, drafting protocols, and executing tests
Details:
- 100% remote (strong preference for Mountain Time; open to ±2 time zones)
- Contract through 12/31 (extension not approved yet, but "good people" often retained)
- Two-step interview process, both virtual: one step focused on soft skills, one step focused on technical skills
- Timeline: interview within approximately one week after a strong resume is identified
- 8am-5pm Monday to Friday, flexibility as needed