Manufacturing Engineer

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Somerset, WI, USA
In-Office
Mid level
Healthtech • Manufacturing
The Role
Design, develop and improve manufacturing processes and equipment to meet product and quality requirements. Lead projects from concept to production launch, create work instructions and validation protocols, reduce waste, support quoting/production, and implement process improvements and automation to improve efficiency, cost, safety, and quality.
Summary Generated by Built In

POSITION SCOPE AND PURPOSE: Develop and implement optimal, cost-effective manufacturing processes and methods in accordance with product specification and quality standards. Recommend and implement improvements to production processes, methods and controls. Manage project from concept through manufacturing launch for new or revised projects.

KEY ACCOUNTABILITIES/ESSENTIAL FUNCTIONS:

  • Identifyareas of waste in our manufacturing processes to include but notbe limitedto scrap and reject reduction, equipment downtime, earned hours per employee and process/equipment changeovers.
  • Prioritize and manage projects and tasks necessary to deliver to the need of the customer(s). Efficiently utilizes available resources and engineering tools.
  • Properly analyzes, develop and procure all aspects of a project from inception through successful completion for the life of program. Generate processes that are robust and exceed the criteria established by customer while supporting SMC's financial metrics.
  • Leverage the available engineering resources and software to understand our manufacturing processes and data so that accurate decisions can be made. Generate clear and concise standard work instructions and other technical documents that are appropriate for the end user.
  • Regular Attendance

OTHER POSITION DUTIES:

  • Recommend and implement process improvements and corrective actions to include but not limited to automation and equipment improvements.
  • Research, plan, design and develop manufacturing processes maximizing efficiencies, analyzing layout of equipment, workflow, assembly methods and work force utilization.
  • Aid in the release to manufacturing of new/revised products including establishing goals, training team members and evaluating results.
  • Provide technical support for the continual improvement of operation and products, with emphasis on improving competitive advantage and determining appropriate applications of the latest technology that supports that strategic plan.
  • Analyze and evaluate manufacturing methods and provide solutions for problems that adversely affect costs, operator safety, productivity and quality.
  • Provide support to Quoting, Production and other departments as required.
  • Responsible for creating, documenting, developing and implementing procedures used to manufacture all products including IQ, OQ, PQ protocols.
  • Design, develop and test various machinery and equipment for manufacturing methods.
  • Manage and engineer projects from concept through production on a limited basis by the following:
  • Being responsible for the financial objectives of the project. Maintain set margins in tooling, equipment and part pricing.
  • Being responsible for assigning tooling and equipment vendors on new and revised projects.
  • Being able to establish clear communication and project schedules through the use of regular status letters and Gantt charts.
  • Providing leadership and demonstrating the ability to lead functional teams as required to accomplish the project objectives.
  • Review first time samples on new tools and equipment with the Technician, Project Engineer and Quality Assurance as required.
  • Conduct and document time studies to establish performance standards.
  • Review product cost requests for cost estimates on changes.
  • Alert production control of any existing issues on production jobs that may affect customer orders.
  • Other duties as assigned.

QUALIFICATIONS:

  • BSME or equivalent experience.  
  • Technical skills in manufacturing processes i.e. molding, tooling and all value added operations and methods including flow, layout, assembly and production equipment.
  • Strong interpersonal, leadership and communication skills.
  • Strong team player.  
  • Computer proficiency.
  • Ability to read, write and communicate in English.

PHYSICAL REQUIREMENTS AND ENVIRONMENTAL CONDITIONS: 

  • Medium work: Exerting up to 50 pounds of force occasionally and/or a negligible amount of force constantly to move objects.  
  • Ability to work for extended periods sitting and looking at computer while completing repetitive motions to include substantial movements (motions) of the wrists, hands, and/or fingers.
  • Close visual acuity to perform an activity such as preparing and analyzing data and figures; reviewing detailed information; viewing a computer terminal; and expansive reading.
  • The ability to manage a number of projects at one time with frequent interruptions and tight deadlines.
  • Climbing, Balancing, Stooping, Kneeling, Crouching, Crawling, Reaching, Standing, Walking, Pushing, Pulling, Lifting, Fingering, Grasping, Feeling, Talking, and Hearing.
  • This position works in a variety of physical conditions, such as proximity to moving mechanical parts and electrical current.

Skills Required

  • BSME or equivalent experience
  • Technical skills in manufacturing processes (molding, tooling, flow, layout, assembly, production equipment)
  • Experience creating and implementing manufacturing procedures and validation protocols (IQ, OQ, PQ)
  • Strong interpersonal, leadership and communication skills
  • Team player
  • Computer proficiency
  • Ability to read, write and communicate in English

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The Company
Somerset, Wisconsin
1,795 Employees
Year Founded: 1988

What We Do

SMC Ltd. offers global solutions, contract manufacturing and molding services for the medical device, diagnostics, and pharmaceutical industries. Services include design, engineering, thermoplastic molding including insert, two-shot and micro, liquid silicone injection molding (LIM) and complete device assembly. Project integration, supply chain management, validation, packaging and labeling, and sterilization responsibility are systematically controlled. Facilities offer ISO 13485, quality systems, white room, class 7 and 8 clean rooms. SMC Group: Oval Medical Technologies, an SMC Ltd. company, is a medical device company developing in revolutionary autoinjector platforms. Oval’s unique approach allows for devices that are smaller, easier and safer to use than any other device currently available. Pharmaceutical partners can utilise Oval’s technology to deliver viscous formulations and sensitive biological drugs that would otherwise not be possible to deliver in current marketed injectable devices. Oval is able to tailor the technology for specific patient populations producing devices that are truly patient centric. www.ovalmedical.com

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