Govcio LLC

Experience/Skill/Job Requirements:
BS degree in engineering discipline, or equivalent
5+ years industry experience
Medical device experience
Familiarity with design controls risks, trace reports, design controls
Strong writing and grammar skills in areas of content development and writing style. Analytical ability to swiftly grasp and effectively communicate complex technical engineering concepts.
Excellent written and verbal communication skills with a proven ability to present information in a clear and concise manner to various technical, business stakeholder, and leadership audiences

Preferred Qualifications and Skills:
While the candidate is expected to have some of the following skills, a strong propensity for learning and the ability to synthesize new information effectively will be highly valued:
Experience creating or modifying risks, trace reports, functional requirements, etc.
Knowledge of medical device regulations, both US and OUS (e.g., FDA regulations, MDR, China PTR, etc.).
Experience working with design control software (MKS, Polarion, etc.).
Strong organizational skills and the ability to manage deliverables under tight deadlines, set priorities, and manage time effectively.
Team player with the ability to interface with technical SMEs and business stakeholders across multiple disciplines to achieve the best outcomes.
Ability to quickly learn new tools, drive process improvement, and manage change.
Demonstrated ability to understand, resolve, and communicate technical and business issues.
Organized and detail-oriented, with a high level of integrity and reliability.
Excellent analytical and problem-solving skills with attention to detail; mission-critical production support experience.
Solid foundation in system engineering principles such as requirements definition, system integration, formal verification, and validation methods.
We look forward to welcoming a dedicated and skilled professional to our team who is passionate about contributing to the success of our projects and the advancement of our technology.

Job Types: Full-time, Contract

Pay: $65.00 - $70.00 per hour

Expected hours: 40 per week

Work Location: In person