Job Description:

Essential Duties, Responsibilities and Qualifications may include the following.  (Other duties may be assigned.)

Design Engineering:

• Contribute to the design and development of new medical devices:




• Translate customer needs into measurable engineering specifications.


• Utilize CAD software and other design tools to create detailed product designs and specifications.


• Conduct feasibility studies, risk assessments, and design validation activities


• Make tradeoffs between technical attributes of product design including function, aesthetics, cost, material selection, and manufacturability.


• Assist with ensuring design control is within compliance with global regulatory standards and requirements (ISO, FDA QSR, MDR)




• Strong knowledge of injection molding design criteria


• Collaborate with cross-functional teams, including Product Management, Quality, and Manufacturing, to ensure seamless product development processes.


• Work closely with external partners and suppliers to facilitate the transfer of designs into production.


• Contribute to the continuous improvement of design and development processes.

Quality Assurance:

• Generates quality system and project related documentation as needed (i.e. FMEA, Design History File documents, work orders, charters). 


• Ensures product designs meet all safety related clinical indications for use (i.e. biocompatibility, sterility, reprocessing)


• Utilizes statistical techniques and programs to make part design tolerancing decisions.


• Understands and follows company Quality Management System SOPs

Personal Development: 

• Attends all relevant training.

• Stay informed about industry trends, new technologies, and emerging best practices in medical device design.

• Commitment to growing professionally by utilizing a career development plan.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed above 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

Minimum of a Bachelor's degree (BS) in engineering from a four-year college or university; three to five years related experience and/or training; or equivalent combination of education and experience.

Other Skills and Abilities

• Demonstrates design, documentation, materials selection, design for manufacturing, process management, and troubleshooting/problem solving skills.


• Demonstrates interpersonal, organizational and time management skills.


• Demonstrates good communication skills and attention to detail.


• Experience with Microsoft Office (Word, Excel, Outlook, Teams, PowerPoint)


• Experience with Computer-Aided Design (CAD) tools (including 3D modeling) and Product Data Management (PDM) software. CREO & Windchill or similar experience highly preferred.


• Experience with Tolerance loop or geometric tolerance stack up techniques.


• Related experience in medical device development is preferred.


• Requires face-to-face interaction with team members, peers and management to complete work and provide support.


• May be required to occasionally travel between Coralville Iowa headquarters and the Kalona Iowa manufacturing facility.


• Demonstrates and promotes CIVCO Values.

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.  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 the 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)

Engineering

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