Development Engineer I

Aequor JD ·www.aequor.com

Location Warsaw, IN
Work type Remote
Salary USD 59 / hour
Type Full time
Level Mid
Source Shazamme
Engineering
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Job Title: Systems Design / Product Development Engineer

6 Months Contract with high possibilities of extension
Warsaw, IN

Job Description

We're looking for a Systems Design / Product Development Engineer to support development of a software-based medical device (SaMD). The ideal candidate has a solid foundation in systems engineering and product development within a regulated environment, with hands-on experience drafting and maintaining design history file (DHF) content. This role plays a key part in refining and updating existing product documentation and ensuring continued regulatory alignment as the product moves through its lifecycle.

This role is open to remote candidates able to work Mountain Time hours, though candidates based onsite in Salt Lake City, UT are preferred.

Responsibilities

  • Draft and maintain DHF content including user needs, system/design requirements, software requirement specifications, design inputs, traceability matrices, and risk documentation

  • Support risk analysis activities (e.g. FMEAs) and contribute to usability engineering activities

  • Support V&V activities including drafting, execution and creation of test cases, reports and other testing artifacts

  • Collaborate cross-functionally with R&D, QA, Clinical, and Regulatory to translate technical information across stakeholder groups

Requirements

  • 5 years of experience in systems design/product development within a multi-disciplinary organization

  • Demonstrated experience with SaMD development and regulatory documentation

  • Working knowledge of ISO 14971; familiarity with ISO62304 and IEC 62366 preferred

  • Experience drafting DHF artifacts (user needs, requirements, traceability matrices, risk files)

  • Experience in a regulated, compliance-driven environment (FDA/QMS)

  • Strong analytical skills and sound technical judgment

  • Excellent written and verbal communication skills, with ability to work effectively with internal and external collaborators

  • Experience with Codebeamer, JIRA, or similar requirements/traceability tooling

Education

Bachelor's degree in Engineering or a related science field; Biomedical Engineering preferred.

Frequently asked questions

Who is hiring for the Development Engineer I role?
Aequor JD is hiring for the Development Engineer I position, a Shazamme client. Apply directly on the employer's career site.
Where is the Development Engineer I job located?
The Development Engineer I role with Aequor JD is based in Warsaw, IN, US. The role is remote-friendly.
Is the Development Engineer I role remote?
Yes — the Development Engineer I position at Aequor JD is remote. Candidates based in US are preferred.
What does the Development Engineer I role pay?
Aequor JD lists the Development Engineer I role at up to USD 59 per hour.
Is the Development Engineer I role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Development Engineer I role?
The Development Engineer I position is aimed at mid-level candidates.
How do I apply for the Development Engineer I role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.
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