Senior Systems V&V Engineer

Job Title: Senior Systems V&V Engineer Job Function: Quality Consultant Location: Pittsburgh, PA

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM is looking for a Senior Systems Verification and Validation (V&V) Engineer. The selected candidate will work as a V&V Lead to coordinate all V&V activities necessary to support the release of new and updated medical devices. Focus will be assessing and testing the requirements of electromechanical medical devices at the system, sub-system, and part level.

Primary Responsibilities

Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).

Interact with cross-functional project teams to provide inputs to project plans and schedules.

Estimate resource needs for project support.

Review requirements and scrutinize for testability.

Develop V&V test plans, test procedures, requirements trace matrices, and test reports.

Assign project tasks and responsibilities to V&V team.

Act as advisor to team to meet schedules and solve technical problems.

Quickly learn to use automated test tools and specialty test equipment; develop and validate novel test methods (TMV, DOE, Gage R&R studies).

Execute test procedures both personally and using test technicians.

Log defects and issues found during V&V activities and track to closure.

Participate in defect review boards.

Perform regression analysis and determine testing associated with design changes.

Plan and facilitate V&V formal technical review and design review meetings.

Provide weekly project status reports.

Prioritize project tasks to complete on schedule while maintaining quality of work.

Work in a team environment; peer review work.

Work on multiple, concurrent projects.

Qualifications

5 years of professional experience in the medical device industry.

Working knowledge of global medical device regulations, requirements, and standards.

Education & Certifications

Bachelor's Degree in an engineering discipline; electrical engineering or mechanical engineering background preferred.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.

Operate other office productivity machinery, such as a calculator, scanner, or printer.

Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

#LI-DNI