Duration: 012 Months Contract (Possible Extension)

About the role:

· Provides engineering support for integration activities for an acquisition.

· This position is a contract role, expected to complete by the end of July 2025.

· Provides oversight of the design, quality, manufacturing, and project related activities.

· Coordinates with internal functions and external suppliers to identify and execute projects.

· Applies project management and problem solving skills to manage multiple activities concurrently. Develops products, materials, processes, or equipment for projects of moderate complexity. Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.

· 5 - 15% domestic travel possible

Your responsibilities include:

· Ensuring all Design Controls aspects of an acquisition are remediated through:

o Developing new requirements, sourcing new requirements, creating and validating new test methods, creating new risk documentation, and performing all applicable testing

· Supporting manufacturing moves from one vendor to another.

· Supporting project work for EUMDR approval.

· Maintains product safety, quality, and compliance of all products.

· Trained in all aspects of change management (DCA, SCIA, SCAR, and PLCP).

· Supports any applicable R&D projects planning and activities.

· Understands and complies with all the regulations governing the quality system.

· Supports additional activities required by the business.

What we’re looking for:

· 2 years working with design controls.

· 2 year project leader/manager experience.

· 2 years working within FDA Quality System Regulations and ISO 13485.

· Experience with assessing quality and compliance impact on products for design and process changes.

· Experience with design verification and validations activities.

· Experience with Test Method development.

· Experience in troubleshooting and root cause analysis.

· Self-motivated individual that can work independently.

· Working knowledge of MiniTab and SolidWorks.

· Good writing (assessments, protocols, reports, and email) and verbal communication skills.

Preferred Qualifications

· Has led 4 projects to drive product design changes or process changes preferred.

· 3 years of Electro/Mechanical experience.

· Has participated in 4 new product development projects, related product transfer and scale-up activities preferred.

· Knowledge of manufacturing processes including; silicone molding, laser welding, resistance welding, small part assembly, cleanroom operations, vision inspection systems, soldering, electronic component assembly, electrical testing and packaging.

· SAP and Windchill experience is a plus.

· Human Factors / Usability experience is a plus.

Qualifications

5 - 8 Years with BS, 3 - 6 Years with MS, 0 - 3 Years with PhD

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 know 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.

Recruiter Details:

Name: Kanika

Email: kanika.d@ustechsolutionsinc.com

Internal Id: 24-13579