Manufacturing Engineer-Clean Room

Job Title: Manufacturing Engineer – Clean Room

Employment Status: Full-Time

Classification: Exempt

Work Schedule: Monday-Friday

Reports to: Mechanical Engineer

Supervisory Responsibilities: Yes

Working Location: Waupaca

Position Summary: The Manufacturing Engineer – Clean Room is responsible for new product/process development, implementation, documentation, and validation of finished goods and subassemblies in the ISO8 clean room. This position will work directly with the customer and facilitate all activities in the product development and line extension projects.

Essential Functions

  • Leadership: Foster collaboration and creativity in our product development efforts through project management, planning, involvement and communication.
  • Product Development: Develop and implement new processes for assembling and testing devices in the clean room environment
  • Documentation: Generate all documentation required to support the development and validation of goods assembled in the clean room. Provide clear and concise summary reports for all activities in the manufacturing operation. Examples include standard operating procedures for assembly, packaging, and testing, and Maintenance procedures for equipment and clean room.
  • Equipment/Process Improvements: Direct strategic and tactical activities to improve processes and meet ongoing production requirements for safety, quality and cost. Build an understanding of costs and apply a structured problem solving approach to reduce inefficiencies and drive continuous improvements within accepted process parameters or validated ranges of operation. If outside of validated ranges, coordinate validation activities for any changes including final product performance testing with R&D. Requires active involvement with appropriate workforce to clarify and identify equipment/process issues and implement timely solutions that meet company goals and objectives.
  • Production Support: Provide technical support for day to day operations after product launch to improve quality and efficiency.
  • Execution: Approach all projects with a focus on ensuring compliance with regulatory, safety and quality system requirements, including completing the documentation required. Collaborate with all departments, impacted employees, and contractors ensuring a safe and efficient outcome with appropriate training, procedures, and practices that address current and future needs.
  • Device Assembly Support: Support device assembly operations for non-clean room operations.
  • Other: Perform other Engineering work as assigned

This is not meant to be a comprehensive listing of activities, duties, and responsibilities. These items may change or new items may be assigned with or without notice.

Experience and Education Requirements

Minimum Education (or substitute experience) required:

  • 4 year degree in Mechanical Engineering or Manufacturing Engineering.

Minimum Experience required:

  • Minimum three years of industry experience. Prefer candidates with a proven track record of successfully launching products on a tight timeline.
  • Experience sourcing injection molded parts and process development of heat bonding equipment would provide the candidate with a competitive advantage.

Knowledge, Skills, and Abilities (KSA’s) Required

  • Highly organized with strong problem solving skills.
  • Self-starter that requires minimal direction.
  • Proficient with Excel & Microsoft Office Suite.
  • Ability to analyze product and process requirements, development and execute project plans of limited scope, a quality focus, good oral and written technical presentation skills, teamwork.

Other Qualifications

  • Valid Driver’s license with acceptable driving record.

Physical Requirements

The physical demands listed are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Modified “light duty” restrictions may be arranged as needed and when available for job-related injuries or illnesses.

While performing the duties of this job, the employee is regularly required to walk on normal and

uneven surfaces and sit; use hands for writing and keyboarding; lift and/or move up to 20 pounds.

The employee is occasionally required to lift, carry, and push up to 50 pounds; stand, stoop, and bend. The employee is required to use a ladder when necessary. The employee may occasionally encounter uneven and/or slippery surfaces. Driving will be required on occasion.

Specific vision abilities required by this job includes close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.

Acute hearing is necessary for telephone and in-person communication with customers and fellow employees, and visual acuity sufficient to read a computer screen and paper documents.

Working Conditions

Combination of office and plant environments; hot and cold conditions may exist depending on external weather conditions. Exposure to various chemicals and customer supplied fluids. May be exposed to wet/high humidity conditions during product testing.

EEO Policy Statement:

Gusmer Enterprises, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Gusmer will also consider requests for reasonable accommodations made by applicants and employees on an individualized basis, including those based on disabilities and sincerely-held religious beliefs, where such accommodations do not impose an undue burden on the business. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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