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WHK Operations Engineering Manager

Location: Clearwater
Posted on: May 12, 2022

Job Description:

SUMMARYLead and manage the WHK Engineering team to ensure production and clean-room obstacles and overcome, complete assigned engineering projects, launch new products, and seek areas of improvement and implement solutions to identified problems. 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. Promote safety, housekeeping and area improvement initiatives. Manage and develop the WHK Engineering team, assigning goals and objectives to direct reports and ensuring that adequate progress is made and appropriate training is coordinated Maintain all WHK equipment, fixtures, and molds. Set up and coordinate equipment calibration programs and preventative maintenance programs. Lead the engineering support required to maintain all WHK cleanroom facilities and their ISO Class 7 Certifications. Lead the support of WHK operations when there is a problem that limits or stops production, taking responsibility for ensuring production can resume safely Proactively address manufacturing areas of improvement by suggesting and leading projects to improve productivity, safety, and profitability 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. Develop machine specifications for new equipment and ability to develop and modify equipment layout to generate process flow. Identify potential equipment upgrades and/or new equipment requirements and the ability to complete cost analysis and justification for any capital request. Understand 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. Lead and participate in FMEA's as required by WHK SOP processes Contribute to ECOs as assigned by the ECO Control Board Other duties as assigned.

Teamwork is essential for TSE's continued success, so Teamwork is an essential function of every employee's job. Teamwork drives positive results every day. Teamwork promotes positive customer relations and results in exceeding the expectations of our customers. Teamwork benefits every employee since it grows our business and increases our sales. Teamwork with co-workers in the same department is just the beginning. Teamwork with every other employee, department and division is the Teamwork that is required to succeed. WE ARE TSE.SUPERVISORY RESPONSIBILITIESMay directly supervise operators or specialists in WHK. May have supervisory and leadership responsibility for other Engineers and technical resources within WHK. Carry out supervisor responsibilities in accordance with the organization's policies and applicable laws. SAFETY TRAINING To perform this job successfully, an individual must complete and maintain the following Safety Training requirements.General Safety Orientation Hearing Protection TrainingQUALIFICATIONS 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 EXPERIENCECollege degree (BS) required in an Engineering discipline. Must have minimum of 3-5 years manufacturing experience in an ISO 13485 regulated environment. Clean Room Facility Management or Engineering experience is highly desired. 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. At least 3 years Project Management experience required, Project Management certification is a plus. At least 5 years experience in design and 3D CAD programs. At least 5 years experience with leading equipment and process validations. At least 3 years experience in management of an engineering staff. Hands on experience with Injection Molding and overmolding of Plastics and/or Silicones is desired. LANGUAGE SKILLSMust possess the ability to express thoughts clearly, both verbally and in written context. Ability to write reports and business correspondents. Ability to communicate effectively. Must have strong knowledge in working with the MS Office Suite. MATHEMATICAL SKILLSAn understanding of all basic mathematical skills. An understanding of trigonometry and angular relationships is necessary in order to understand and interpret blueprints.REASONING ABILITYShould 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 weighing > 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.PI177047318

Keywords: T S E INDUSTRIES INC., Clearwater , WHK Operations Engineering Manager, Engineering , Clearwater, Florida

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