Job Description
The Manufacturing Engineer leads the development, optimization, and implementation of manufacturing processes. This role focuses on improving efficiency, reducing costs, and meeting quality standards while collaborating with design and R&D teams to ensure the manufacturability of new products.
ResponsibilitiesDesign and implement manufacturing processes that improve efficiency, reduce costs, and meet quality standards.Analyze existing workflows and identify opportunities for automation, standardization, and waste reduction.Collaborate with design and R&D teams to ensure manufacturability of new products.Engage in hands-on process design, development, validation, and manufacturing transfer.Develop test methods and reports.Release equipment installation and operation qualifications.Collaborate with engineering to develop, document, and build prototypes, tooling, and fixtures to produce vascular medical devices according to design, quality specifications, and budget.Provide technical expertise and guidance to resolve complex manufacturing issues.Lead troubleshooting and root cause analysis for process and equipment failures.Lead manufacturing start-up projects.Plan and manage manufacturing projects, ensuring timely delivery and alignment with organizational goals.Coordinate with cross-functional teams, including operations and quality.Monitor project performance, adjusting strategies as needed to achieve desired outcomes.Track material lead times, scrap rates, and product delivery schedules.Support product transfer from R&D to pilot production and full production through training and process development.Interact with outside vendors including third-party sterilizers and contract testing labs to accomplish project deliverables.Ensure all processes comply with company standards, regulatory requirements, and industry best practices.Partner with the quality team to implement and maintain robust quality control measures.Maintain lab notebook practices and GMP in accordance with company quality procedures.Support and manage product development and manufacturing efforts including product testing, recording and analyzing data, and writing procedures and reports.Drive a culture of continuous improvement using Lean, Six Sigma, or other methodologies.Monitor production data to identify trends and implement corrective actions proactively.Implement cost reductions by working closely with production to reduce scrap and waste and improve efficiencies.Essential Skills5+ years of experience in manufacturing engineering within a regulated environment, preferably medical device or aerospace.Knowledge of medical device testing and FDA requirements.Proficiency in CAD software, ERP systems, and manufacturing tools.Strong knowledge of Lean manufacturing principles.Project Management skills.Six Sigma methodologies certification.Additional Skills & QualificationsBachelor’s degree in Mechanical, Industrial, Manufacturing Engineering, or a related field.Knowledge of manufacturing methods for vascular catheter systems.Lean manufacturing training and experience preferred.Familiarity with statistical process control and metrology.Work Environment
Work is performed primarily in a standard office environment and manufacturing setting. The company recently added a new facility where they are building out a manufacturing line, marking the first time they have manufactured devices. They recently added a clean room. The role involves spending 60% of the time on the manufacturing floor and 40% at a desk writing test reports. The company is a pioneer in surgical navigation and precision healthcare, empowering physicians with safe, real-time imaging solutions that improve outcomes, lower costs, and reduce radiation exposure for both patients and caregivers in minimally invasive endovascular procedures.
For questions or to apply can contact Christopher Davis at 330 -842 -1023 (call/text) or through email at chridavi @actalentservices.com
Pay and BenefitsThe pay range for this position is $48.00 - $53.00
• 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 Cleveland,OH.
Application Deadline
This position will be accepting applications until Dec 24, 2024.
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 & InclusionAt 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 peopleThe 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.