Test Engineer Verification and Validation

Verification and Validation Test Engineer at BiaCure Therapies

Milwaukee, Wi

Contribute to advancing devices for treating nail diseases while working for a company that respects, values, and appreciates all team members. Contribute, help grow and be part of an exciting startup company whose mission is to improve the quality of life of the patients we treat.

Why you’ll love working at BiaCure Therapies:

· Strong mission to expand access one of the most new and unique devices in healthcare

· Company-wide dedication to clinical excellence, innovation, and teamwork

· Opportunity to take ownership and drive new design projects

· Career development through fast pace and an all-hands-on-deck culture

· Mentorship from some of the top industry experts

· Flexible working hours, including paid vacation and holidays

· Healthcare programs including medical, dental, and vision

· 410(k) retirement plan

· Company paid life insurance

Job Summary:

As a verification and validation test engineer at BiaCure Therapies, you will be part of a new team that is designing, prototyping, testing, and producing unique devices and accessories that advance the treatment of nail disease. You will work on projects from conception to manufacture, collaborating with system engineers, electrical engineers, software engineers, clinicians, quality and regulatory individuals to ensure our work continues to enhance patient outcomes while providing excellent value for our customers. Strong collaboration with team members is critical.

Responsibilities:

· Coordinate and lead integration and verification test activities.

· Design and write verification and validation protocols for created designs.

· Coordinate clinical and benchtop testing activities.

· Design and implement test cases and procedures.

· Investigate and troubleshoot issues found during testing.

· Coordinate and implement test tools and fixtures needed for testing activities.

· Develop Design History File (DHF) test deliverables.

· Participate in Risk Analysis activities.

· Participate in final test result reviews.

The ideal candidate will be able to:

· Create and implement test cases and produce test reports that comply with company standards.

· Product clear and concise documentation concerning testing activities.

· Strong attention to detail and organizational skills.

· Be a strong cross-disciplinary team member. Excited to work with and learn from software, mechanical, and electrical engineers, as well as communicating with subject-matter experts outside of these disciplines.

· Work independently on testing needs and keep good communication with other team members.

· Work with other engineers to drive and achieve project milestones.

Qualifications:

1. Minimum of a Bachelor of Science degree in an engineering discipline required.

2. 3-5+ years of experience in a product testing environment.

Problem-solving and troubleshooting design experience preferred.

Test scripting languages or other programming techniques preferred.

Knowledge of FDA Quality System and Design processes preferred.

Previous medical device or other regulated industry required.