WHK Operations Engineering Manager
Company: T S E INDUSTRIES INC.
Location: Clearwater
Posted on: May 12, 2022
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Job Description:
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.
Requirements:
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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