"Alerted.org

Duration: 12 Months Contract

Hybrid

9:00am-5:00pm

Job Summary:

Lead cross-functional teams in complex engineering assignments, ensuring compliance with medical device regulations and effective project execution. This role requires a strong focus on project management, collaboration, and problem-solving across traditional product lines.

Primary Responsibilities

• Independently plan, execute, and direct cross-functional engineering projects, adapting standard engineering principles to develop innovative solutions.

• Manage projects consisting of cross-functional teams (including but not limited to regulatory, risk management, quality, technical communications, and supplier quality)

• Oversee all financial aspects of product development, including capital expenditures and cross-functional expenses.

• Identify and resolve complex problems, developing new solutions as needed for project roadblocks

Knowledge

• Medical Device Regulations: In-depth understanding of FDA regulations, ISO standards, and other relevant guidelines governing medical device labeling and compliance.

• Project Management Methodologies: Familiarity with project management frameworks (e.g., Agile, Waterfall) and tools (e.g., Gantt charts, project management software).

• Engineering Principles: Strong foundation in engineering principles relevant to medical device design and development.

• Quality Management Systems (QMS): Knowledge of QMS practices and documentation requirements.

• Cross-Functional Team Dynamics: Understanding of the roles and responsibilities of various departments involved in medical device development.

Skills

• Project Management Skills: Proven ability to manage multiple projects simultaneously, ensuring timely delivery within budget.

• Analytical Skills: Strong analytical and problem-solving skills to identify issues and develop effective solutions.

• Attention to Detail: Meticulous attention to detail in reviewing labeling documentation.

Qualifications

• Bachelor’s degree in engineering or a related field.

• 8-10 years of relevant experience in project management, with a focus on medical devices.

• 2-5 years of experience in matrix management.

• Thorough, up-to-date knowledge of multiple engineering disciplines.

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To learn more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions 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.