Manufacturing Engineer

Additional Skills & Qualifications

• Educational Background: A degree in Mechanical, Materials, or Biomedical Engineering is typically required.
• Experience: Preferably 1-5 years of manufacturing engineering experience in the medical device industry.
• Cross-functional team communication
• Six Sigma and Lean Manufacturing knowledge

MUST HAVE

• Hands-on experience in Equipment/Process Validations (IQ/OQ/PQ).
• Proficiency in CAD software (e.g., SolidWorks) for fixture design, development, and verification.
• Experience with sampling plans and statistical analysis.
• Knowledge of Quality Systems pertaining to medical device development and manufacturing.
• Process Improvement: Demonstrated ability to implement process improvements and cost efficiencies.
• Vendor Coordination: Experience in coordinating with vendors to source equipment.
• Documentation: Ability to develop and update Standard Operating Procedures (SOPs) and manufacturing procedure documents.
• Teamwork: Provide leadership, training, and mentorship to less experienced team members. Ability to work independently and with internal and external stakeholders.
• Problem-Solving: Strong problem-solving skills and the ability to manage and prioritize multiple tasks/projects.
• Regulatory Knowledge: Familiarity with FDA, ISO standards, clean room standards, and other medical device regulations.

Job Description

We are seeking a Manufacturing Engineer to join our diverse team. In this role, you will provide engineering support to a manufacturing process, project, or function. You will evaluate manufacturing outcomes and implement continuous improvements and cost efficiencies. You will support New Product Introduction (NPI) and new equipment/process introductions. This is an individual contributor role that requires the use of judgment in applying professional expertise and is expected to work independently with minimal supervision.

Responsibilities

• Provide engineering support for new product and new process introduction, ensuring that all activities are completed and documented in accordance with the New Product Development Process.
• Evaluate manufacturing outcomes and implement continuous improvements and cost efficiencies.
• Develop and implement appropriate supporting documentation, Standard Operating Procedures (SOPs), and process work instructions compliant with current Good Manufacturing Practices (GMP).
• Monitor line performance and compile and execute structured event plans to remediate systemic issues that drive sub-optimal performance.
• Provide technical leadership on all product and process issues.
• Foster a work environment of continuous improvement that supports Quality Policy, Quality System, and the appropriate regulations for the area they support.
• Actively interface with cross-functional team members and third-party vendors, practicing good teamwork in support of day-to-day operating requirements and in pursuit of achieving business targets.

Work Environment

This position is based on the manufacturing floor and follows a Mon-Fri 8-5 schedule.

Pay and Benefits

The pay range for this position is $30.00 - $50.00/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 Salt Lake City,UT.

Application Deadline

This position is anticipated to close on Apr 11, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $30 - $50