R&D Software Test Engineer — Medical Device Innovation

Generis Tek Inc; Minneapolis (MN); On-site; USD 110,000 - 120,000; Full time

Job summary

Generis Tek Inc is seeking a Software Test Engineer to join our R&D team in Plymouth, MN. The role focuses on leading software test workstreams across product and non-product ecosystems and collaborating with developers to ensure rigorous documentation and testing.

The ideal candidate has a BS in CS/SE/EE, 2+ years in software testing, and knowledge of IEC 62304 and FDA/EU regulatory standards. This is a 6-month contract on-site in Minnesota.

Qualifications

• Bachelor's degree in CS/SE/EE or similar.
• Minimum 2 years of relevant experience.
• Experience in C/C family of languages.
• Familiarity with IEC 62304 software testing approaches.
• Experience with FDA 21 CFR Part 820, EU-MDR, ISO13485 compliance.
• Familiarity with static and dynamic unit test tools and repositories.
• Ability to work with software developers to produce test docs.
• High motivation and curiosity to solve challenges.

Responsibilities

• Lead software test workstreams across product and non-product ecosystems.
• Provide technical leadership within a cross-functional R&D team.
• Collaborate with developers to produce concise test documentation.
• Meet evolving business needs as directed by management.

Skills

C/C language experience

IEC 62304 familiarity

FDA/CE regulatory knowledge

Software test methodologies

Unit test tools (static/dynamic)

Code repositories familiarity

Documentation collaboration

Motivation & curiosity

Education

Bachelor's degree in CS/SE/EE

Advanced degree preferred

Job description

Generis Tek Inc is seeking a Software Test Engineer to join our R&D team in Plymouth, MN. The role focuses on leading software test workstreams across product and non-product ecosystems and collaborating with developers to ensure rigorous documentation and testing.

The ideal candidate has a BS in CS/SE/EE, 2+ years in software testing, and knowledge of IEC 62304 and FDA/EU regulatory standards. This is a 6-month contract on-site in Minnesota.