WHK Manufacturing Engineer

About this Position

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 the ERP system for new part introduction and for any process changes. Promote safety, housekeeping, and area improvement initiatives.

• 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.
• Assist with developing machine specifications for new equipment and modify equipment layout to generate process flow.
• Identify potential equipment upgrades and/or new equipment requirements and complete cost analysis and justification for any capital request.
• Understand Continuous Improvement tools and Lean 6‑Sigma concepts and guide Kaizen events and improvement efforts.
• 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.
• Work within a Clean Room environment and possess knowledge of acceptable practices and management of change in such an environment.
• Have good communication skills and the ability to work well with others in a team environment.
• Create part drawings, tool drawings, and 3D models of new parts and assemblies.
• Develop, monitor, and report key production KPIs during daily production meetings.
• Create work instructions, batch sheets, and process standard work for existing and new operations.
• Assist with coordinating equipment calibration programs as well as managing equipment preventive and predictive maintenance programs.
• Revisit established production methods to seek opportunities for improvement in safety, quality, and productivity.
• Assist with special projects as needed.

• General Safety Orientation
• Hearing Protection Training

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.

College degree (BS) required in an Engineering discipline. Must have a 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.

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.

Understanding of all basic mathematical skills. Understanding of trigonometry and angular relationships is necessary to understand and interpret blueprints.

Should be familiar with the different processes required to process materials through a manufacturing environment. This knowledge helps improve processing points throughout the manufacturing operations.

Employees must regularly use their hands, fingers, and arms, talk and/or hear, and be able to lift and/or move up to 50 lbs. Items over 50 lbs should be moved using a team lift approach or appropriate equipment. Specific vision abilities required include close vision, depth perception, and the ability to adjust focus.

Employees may be exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. The noise level is usually loud.