Development Engineer I

Job Location:

Warsaw, IN - USA

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Client is a publicly traded medical device company. Client designs develops manufactures and markets orthopedics products including knee hip shoulder elbow foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world

Job Title: Development Engineer I

Work Location: Warsaw IN 46580

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Job Description:

Were 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 design inputs traceability matrices and risk documentation
Define clear testable requirements and support traceability across the design history file
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:

Bachelors degree in Engineering or a related science field; Biomedical Engineering preferred.

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Overview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Client is a publicly traded medical device company. Client designs develops manufactures and markets orthopedics products including knee hip shoulder elbow foot and ankle ar...