Job Title: Research and Development Engineer IIJob Description

The Research and Development Engineer II will play a crucial role in supporting R&D and cross-functional teams in the design, development, and validation of new products and processes related to medical devices, pharmaceuticals, and biologics. This position demands ensuring that all project and product requirements are clearly specified by stakeholders and customers before planning, executing, documenting, and completing development in compliance with industry regulations.

Responsibilities

Lead and perform software, equipment, and process validations with guidance from R&D Engineering Management.

Assist with the specification, acquisition, and installation of R&D equipment.

Perform equipment and process validations.

Lead or participate in R&D projects for continuous process and product improvement and identify potential issues.

Maintain validation state of control in collaboration with quality assurance.

Contribute to the new products development process.

Conduct statistical analysis and design experiments to support processing development, process control, and process improvement.

Design models and drawings using applicable CAD programs.

Collect and analyze data and prepare key performance reports for management.

Collaborate cross-functionally with Operations, Quality, Regulatory, Supply Chain, and IT departments.

Assist in root cause analysis efforts for CAPA, Nonconforming Product, Deviations, and Investigations.

Support calibration and preventative maintenance programs for R&D equipment.

Essential Skills

Validation protocols and equipment validation experience.

Five years of process validation experience.

Experience in medical devices.

Bachelor's degree in Mechanical, Chemical, Industrial, or Manufacturing Engineering.

Knowledge of regulatory requirements, including FDA 21 CFR Part 820.

Problem-solving and analytical skills with attention to detail.

Mechanically inclined and capable of supporting the regulatory team.

Additional Skills & Qualifications

Experience with V&V, DFM, FMEA, SPC.

Greenbelt certification in Lean Six Sigma.

Ability to support production and the production team.

Work Environment

This is a 100% onsite role with a work schedule from Monday to Friday, starting between 7 AM and 8 AM and ending between 4 PM and 5 PM. The position is initially a 3-6 month contract, with the possibility of extension or permanent placement, though not guaranteed. The work environment fosters a positive team culture and teamwork.

Pay and Benefits

The pay range for this position is $46.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Roswell,GA.

Application Deadline

This position is anticipated to close on Aug 15, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.