Job Information
CIVCO Medical Instrument Co Inc Manufacturing Engineer I in Kalona, Iowa
Description
Summary
The Manufacturing Engineer I is responsible for developing and implementing improved methods of manufacturing, procedures, and processes which result in improved efficiencies, yields, machine operations and quality.
This position is also responsible for providing technical support to the product development group for the implementation of product line expansions and analyzing manufacturing processes to determine if outsourcing is a viable option. It also includes the responsibility for developing and executing process and equipment qualifications, costs analysis, and technology transfer for new and existing processes and equipment.
Onsite/Remote: Preferred Onsite four days a week with eligibility for a hybrid work schedule.
Essential Duties and Responsibilities include the following. (Other duties may be assigned.)
Manufacturing Engineering:
Manufacturing engineering representative for product line expansion projects including product cost estimates, prototype builds, router creation, production transfer, and packaging.
Manufacturing and design engineering resource for small infection control line expansion projects including analyzing product design for manufacturability, product cost estimates, prototype builds, router creation, production transfer, packaging, and manufacturing process definition.
Coordinates and executes process validation and equipment qualifications for new processes and equipment.
Improve and simplify business unit level processes by working with cross-functional teams focusing on Six Sigma and Lean Manufacturing Improvements.
Designs and develops complex fixtures, assemblies, templates, and other manufacturing aids to increase manufacturing yield and throughput.
Analyze new manufacturing processes to make a determination if manufacturing in-house or outsourcing is the most effective option.
Quality Assurance:
Generates and updates quality system (i.e. standard operating procedure and work instruction) and project-related documentation as needed (i.e. qualification protocols/report, design history file documents, work orders, charters).
Understands and follows engineering-related and overall company processes.
Understand and execute manufacturing responsibilities within a regulated quality system such as ISO 13485.
Sourcing:
Manage the qualification and technology transfer of CIVCO processes to quality, cost-effective, and reliable suppliers.
Assist in the development of product and process requirements including raw materials, components, finished product, tooling, fixtures, equipment, and manufacturing systems.
Materials:
Collaborates with quality engineering, as required, to ensure regulatory compliance of new and existing materials.
Technical Knowledge & Leadership:
Maintains intellectual knowledge of new and existing materials, manufacturing equipment and processes.
A manufacturing engineering stakeholder in supporting a company-wide obsession toward achieving and maintaining the highest level of quality, customer responsiveness, and on-time delivery as measured by our clients.
Personal Development:
Attends all relevant training.
Keeps abreast of relevant developments in technology.
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.
Other Skills and Abilities: To perform this job successfully, an individual should have experience with Microsoft Office programs and Computer Aided Design (CAD) software.
Education and/or Experience
Minimum of a Bachelor's degree (BS) in engineering from a four-year college or university; and one to two years related experience and/or training; or equivalent combination of education and experience.
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 sit; reach with hands and arms and talk or hear. The employee is frequently required to use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color 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 essential functions.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to toxic or caustic chemicals and risk of electrical shock. The noise level in the work environment is usually moderate.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)