Job Description

Description:

SUMMARY
Manage and improve all processes with the WHK medical device manufacturing department. Work with Quality to ensure all systems are in compliance with ISO 13485. Implement new processes and assist with onboarding of all new business. Set-up and manage all BOM’s and Routings in ERP system for new part introduction and for any process changes. Promote safety, housekeeping, and area improvement initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Candidate should possess previous experience in medical device manufacturing.
  • Work with Quality to ensure that all processes are in compliance with ISO 13485 requirements.
    • Write IQ/OQ/PQ validation protocols, execute validation protocols for new equipment and process changes, and write summary reports for management review and approval of all validations.
  • Lead, participate, and assist in root cause analysis of customer complaints and process waste issues with accountability for corrective action implementation.
  • Ability to assist with developing machine specifications for new equipment and ability to develop and modify equipment layout to generate process flow.
  • Ability to identify potential equipment upgrades and/or new equipment requirements and the ability to complete cost analysis and justification for any capital request.
    • Understanding of Continuous Improvement tools and Lean 6 Sigma concepts and the ability to guide Kaizen events and improvement efforts.
    • Must possess project management skills and the ability to multitask. Attention to meeting deadlines and customer commitments is critical.
• Interact with customers concerning inquiries. Take new products from inception to prototype and into production.
  • Ability to work within a Clean Room environment and possess working knowledge of acceptable practices and management of change in such an environment.
• Good communication skills and the ability to get along well with others in a team environment is a must.
• Ability to create part drawing, tool drawings, and 3D models of new parts and assemblies.
  • Develop, monitor, and report key production KPI’s during daily production meetings.
  • Ability to create work instructions, batch sheets, and process standard work for existing and new operations.
  • Assist with coordination of equipment calibration program as well as management of equipment Preventive and Predictive maintenance programs.
• Revisit established production methods to seek out opportunities for improvement in safety, quality, and productivity.
• Assist with special projects as needed.

Requirements:

QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE
College degree (BS) required in an Engineering discipline. Must have minimum of 3-5 years manufacturing experience in an ISO 13485 regulated environment. Must have experience working in a Clean Room environment. Prior hands-on experience with injection molding and
extrusion machinery required. MS Office experience required – Outlook, Excel, and PowerPoint. Lean 6 Sigma training and certification highly desired.

LANGUAGE SKILLS
Must possess the ability to express thoughts clearly, both verbally and in written context. Ability to write reports and business correspondence. Ability to communicate effectively. Must have strong knowledge in working with the MS Office Suite.

MATHEMATICAL SKILLS
An understanding of all basic mathematical skills. An understanding of trigonometry and angular relationships is necessary in order to understand and interpret blueprints.

REASONING ABILITY
Should be familiar with the different processes required to process materials through a manufacturing environment. This knowledge would help the individual to be able to improve processing points throughout the manufacturing operations.

PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use their hands, fingers, and arms. Employee is regularly required to talk and/or hear. Employee must be able to lift and/or move up to 50 lbs. The employee is expected to use a team lift approach or the appropriate equipment for items weighting >50 lbs. Specific vision abilities required include close vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. The noise level in the work environment is usually loud.

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