Mechanical Engineer

Actalent, Inc.; Mahwah (NJ); On-site; USD 69,000 - 83,000; Full time

Benefits offered by this job

2 weeks PTO

6 paid holidays

Job summary

Actalent, Inc. in Mahwah, NJ seeks a Mechanical Engineer to design, prototype, and test medical devices. The role emphasizes hands-on prototyping, Creo CAD work, and rigorous validation to meet ISO/FDA standards.

You will collaborate with R&D, manufacturing, and QA to refine designs, perform mechanical testing, and document results. This contract onsite role offers a collaborative environment for rapid prototyping and regulatory compliance.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 5+ years of experience in mechanical engineering, preferably in medical devices.
• Proficiency in Creo CAD software.
• ASME Y14.5 or ISO drafting proficiency.
• Strong understanding of mechanical testing methods and equipment.
• Ability to work effectively in a team and communicate clearly with cross-functional teams.
• Knowledge of ISO/FDA regulatory standards is a plus.
• Experience with rapid prototyping (3D printing, CNC) and mechanical testing equipment.

Responsibilities

• Design, develop, and test prototypes of medical devices.
• Determine when hand calculations are sufficient vs simulations.
• Execute engineering analyses.
• Perform tolerance analysis.
• Conduct mechanical testing and analysis to validate designs.
• Collaborate with R&D, manufacturing, and QA to refine prototypes and ensure manufacturability.
• Develop and execute test plans, protocols, and reports.
• Utilize CAD to create design drawings and specs.
• Perform root cause analysis and implement corrective actions.
• Stay current with industry standards and regulatory requirements for medical devices.
• Document all testing activities per company policies and regulatory guidelines.

Skills

Hands-on prototyping

Problem-solving

Team collaboration

Regulatory knowledge

Education

Bachelor's degree in Mechanical Engineering

Tools

Creo CAD

ASME Y14.5 / ISO drafting

Job description

The Mechanical Engineer will play a crucial role in the testing and prototyping of medical devices. This position requires a versatile engineer with a strong background in mechanical engineering principles, hands-on prototyping skills, and a keen eye for detail. The successful candidate will work closely with cross-functional teams to ensure the reliability, safety, and efficacy of our products.

Job Title: Mechanical Engineer

• Design, develop, and test prototypes of medical devices.
• Understand when hand calculations are acceptable versus when simulations are necessary.
• Execute engineering analyses.
• Perform tolerance analysis.
• Conduct mechanical testing and analysis to validate design concepts.
• Collaborate with R&D, manufacturing, and quality assurance teams to refine prototypes and ensure manufacturability.
• Develop and execute test plans, protocols, and reports.
• Utilize CAD software to create detailed design drawings and specifications.
• Perform root cause analysis and implement corrective actions for design and process issues.
• Stay current with industry standards and regulatory requirements for medical devices.
• Document all testing and prototyping activities in accordance with company policies and regulatory guidelines.

• Bachelor's degree in Mechanical Engineering or a related field.
• 5+ years of experience in mechanical engineering, preferably in the medical device industry.
• Proficiency in Creo CAD software.
• ASME Y14.5 or ISO drafting proficiency.
• Strong understanding of mechanical testing methods and equipment.
• Excellent problem-solving skills and attention to detail.
• Ability to work effectively in a team environment and communicate clearly with cross-functional teams.
• Knowledge of regulatory standards for medical devices (e.g., ISO, FDA regulations) is a plus.

• Experience with rapid prototyping techniques (e.g., 3D printing, CNC machining).
• Hands-on experience with mechanical testing equipment (e.g., tensile testers, fatigue testers).

The position offers 2 weeks of PTO, 6 paid holidays, and a collaborative work environment where you will work closely with cross-functional teams. The role involves utilizing various mechanical testing equipment and CAD software in a dynamic and innovative setting. Dress code is business casual.

Job Type & Location

This is a Contract position based out of Mahwah, NJ.

Pay and Benefits

The pay range for this position is $50.00 - $60.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 Mahwah,NJ.

Application Deadline

This position is anticipated to close on Feb 28, 2025.

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 process due to a disability, please email [e-mail] for other accommodation options.

We collect your phone number and email so that an Actalent representative can reach out to you regarding potential job opportunities. Please ensure that the phone number and email you provide are accurate, as an incorrect phone number or email may affect our ability to contact you.

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.