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Job Title: Mechanical Engineer

Job Description

The Mechanical Engineer in R&D will lead cross-functional teams in executing design changes, product enhancements, and quality projects for medical device products. This role is crucial in ensuring product safety, compliance, and quality through technical leadership, root cause analysis, and adherence to regulatory standards. The successful candidate will drive process and product improvements by analyzing post-market data, customer feedback, and field investigations, collaborating across departments to uphold our commitment to patient safety and customer satisfaction.

Responsibilities

+ Lead cross-functional teams in design changes, product enhancements, and quality projects.

+ Ensure product safety, compliance, and quality through technical leadership and root cause analysis.

+ Adhere to regulatory standards in all design and development processes.

+ Drive process and product improvements by analyzing post-market data and customer feedback.

+ Collaborate with departments to maintain a high standard of patient safety and customer satisfaction.

Essential Skills

+ Bachelor's degree in Mechanical Engineering.

+ 5+ years of experience in product design, preferably with electro-mechanical products using SolidWorks.

+ Experience in root cause analysis and CAPA (Corrective Action Documentation).

+ Proficiency in R&D prototype design and test methods, especially in highly regulated industries.

Additional Skills & Qualifications

+ Experience with FDA Quality Systems Regulation and Design Control requirements.

+ Strong leadership and project management skills.

+ Knowledge of statistical methods and design of experiments.

+ Competency in statistical analysis tools, such as MiniTab.

+ Proficiency with CAD tools and knowledge of manufacturing processes.

+ Excellent technical writing skills for protocols, reports, and risk documentation.

+ Detail-oriented and action-oriented with strong technical learning abilities.

Job Type & Location

This is a Contract to Hire position based out of Newark, DE.

Pay and Benefits

The pay range for this position is $50.00 - $68.00/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 Newark,DE.

Application Deadline

This position is anticipated to close on Dec 30, 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 [email protected] (%[email protected]) for other accommodation options.