Sturtevant, Wisconsin | March 30, 2019
Purpose of the job
The Project Engineer plans, organizes and directs assigned engineering activities to meet company objectives for new product launches for Qure Medical by performing the following duties.
- Facilitate timely engineering of molds and accessory tooling.
- Provide quotations on estimated tooling costs, mold designs, layouts, etc.
- Write purchase orders for molds and other tooling.
- Interface with customers regarding part and mold designs and support Qure sales.
- Maintain extensive knowledge of and act in accordance with ISO13485 quality systems.
- Utilizes AutoCAD, Pro-E and/or Solid Works for rubber 2D and/or 3D mold design.
- Coordinates design of precision rubber molds for injection, hot transfer, cold transfer, and compression molding, along with other applicable tooling to produce elastomer components.
- Reviews and defines customer drawings in conjunction with other Project Engineers, Process Engineers, Program Engineers and Manager of Engineering.
- Coordinates tooling and develops process for new silicone extrusion launches.
- Operates presses and other equipment as necessary throughout manufacturing.
- Reviews work order and procedural manuals for required equipment/processes.
- Active member of APQP teams. Maintains engineering files.
- Actively participates on new product development team with chemists, and manufacturing personnel.
- Works closely with Quadra tooling and outside mold shops to insure the best mold design and build possible to help achieve a goal of zero rework.
Knowledge, skills and experience
- Bachelor’s degree (B.S.) from a four-year college or university; or working towards a B.S.; or equivalent combination of education and experience.
- Minimum 5 years’ experience with rubber and project management
- AutoCAD (or similar) experience
- Low Volume and prototype experience preferred.
- Knowledge of GD&T
- Must Have:
- Experience in HCR and LSR tool design and process
- Pro-E and/or Solid Works expertise
- Wasteless / Flashless tool design and/or process
- See additional requires as outlined in “position requirements for project engineer—catheters/assemblies for medical/pharma
Knowledge/experience required beyond minimum qualification
- 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.
Position requirements for Project engineer—Catheters/assemblies for medical/pharma
Medical device: ISO 13485 & FDA compliance
- Must have thorough understanding of ISO and FDA standards as they relate to finished devices. Communicates with customers and quality staff to make sure we are in compliance with regulatory standards.
- Must have working knowledge and experience on building a complete silicone catheter. Experience with work instructions, procedures, training is important.
- Class VII & Class VIII cleanroom experience is required. Understanding what constitutes a clean environment and what factors effect particulate and microbial growth is important.
- Hands-on Experience with extruding peroxide or platinum cured silicones is required. Mutilumen and stripe extrusion is also a must. Recommending equipment and plant layout is beneficial.
- Experience with LSR Molding, splicing and material selection is required for this position.
- Spicing/skiving, pad printing packaging & coatings regarding catheter or similar silicone related products in a must. Sourcing components and detailing specifications in also important.
- Experience in silicone molding & assembling of balloons is required.
- Strong leadership skills and the ability to establish a timeline and meet dates is critical. This position initially will not have any direct reports, so directing and influencing others to meet timelines without authority will be an important asset to this position.
- Must have good communication skills and ability to interface regularly with customers.
Production environment experience
- Must be familiar with a manufacturing environment and interface with production personnel regularly.
- Must have good mechanical aptitude. Mechanical engineering degree preferred.
- Must have excellent understanding of print reading. CAD design experience preferred.
- Having a well-rounded background in Catheters, understanding capacities, manufacturing rates and material costs, quoting and cost analysis is vital to this position.
- The position requires a high degree of understanding in tooling as it relates to molding, splicing, fixture, extrusion and similar to completely manufacture a catheter.
Other key factors
- Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization
- Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate and percent and to interpret bar graphs.
- Ability to apply common sense understanding to carry out detailed written or oral instructions.
- Basic understanding of computer monitor, keyboard and hard drive.
- 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 hands to finger, handle, or feel and reach with hands and arms. The employee is frequently required to stand; walk; and talk or hear. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Employee will come in frequent contact with various types of machine oils, lubricants and silicone.
- 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.
- The noise level in the work environment is usually moderate.
- Employee may be required to work long hours exposed to high heat and humidity
- All employees will be provided training on working safely, evacuation procedures, accident reporting and any other safety items the company feels necessary to ensure and maintain a safe work environment free from hazards to the employee.
- If at any time you feel unsafe or recognize an unsafe practice, it is your responsibility to report it immediately to your supervisor.