NPI Process Development Design Engineer II

Company Name:
Accellent Inc.
NPI Process Development Design Engineer II
Tracking Code
Job Description
Develops capable processes and ensures efficient and effective transfer of processes and product into production in the most cost effective manner. Responsible for large projects with implications throughout Lake Region Medical.
Employees are expected to support the quality concepts inherent in the business philosophies of Lake Region Medical, including a variety of job related tasks which may not be specific to this position profile.
Accountabilities include:
Assess process capabilities and manufacturing cost margins.
Design tooling and equipment along with processes for new product introduction.
Process incoming quotation requests or orders received for new products requiring process development. Expedite the completion of the documentation required for these requests.
Maintain contact and give informational updates to NPI program manager.
Identify, coordinate and resolve personnel, material, and equipment requirement issues with Engineering, Materials Planning, Production, and other department management.
Direct the functions of personnel from other departments who support New Product Development operations by coordinating their maximum operational efficiency with their Manager or Supervisor.
Assist in corrective action to resolve process or tooling inadequacies. Expedite the completion of these assigned action items by expediting their progress.
Review completed products to assure product performance quality (PPQ) requirements specified by customer and Lake Region are met.
Complete project status reports to define status level of completed product processing.
Provide post order status reports, regarding cost efficiencies, tooling and fixturing issues, manufacturing efficiencies, process capabilities, and actual cost versus quoted costs.
Formulate and conduct equipment validations (IQ/OQ) and process validation (PQs) to insure equipment and process quality.
Deliver accurate estimates of time and cost required to complete required tasks in order to insure customer satisfaction and Lake Regions profitability.
Rapid and accurate LRM ECO generation and maintenance to insure that Lake Region Manufacturing s product drawings and associated controlled documents satisfy FDA requirements.
Apply continuous improvement/lean concepts to identify and eliminate non-value added tasks and/or activities.
Timely and regular attendance.
Perform other duties as assigned.
Required Skills
S. Degree in Engineering or related discipline (ME preferred). Alternately, two years of direct experience in engineering may be substituted for each year of education.
Minimum three (3) to five (5) years related experience in manufacturing engineering positions, preferably in the medical device manufacturing industry.
Experience with medical products and FDA requirements desirable.
Extensive breadth and depth of knowledge of manufacturing equipment and tooling.
Ability to demonstrate skill as a seasoned professional with a full understanding of industry practices and company policies and procedures.
Diverse and highly technical problem solving ability.
Working knowledge of personal computer and ability to use business office software.
Understanding of other business computing operations such as MRP.
Must have above average planning and organization skills.
Specific Areas of Expertise (as applicable):
Wire Forming (grinding & coil winding) A background in mechanical engineering or physics is preferred. The ability to apply concepts of mechanics of materials and metallurgy towards grinding or coil winding.
Assembly Knowledge of bonding similar and dissimilar materials (e.g., metals, plastics) using soldering, epoxy, cyanoacrylate, resistance welding or other as determined.
Coatings A background in chemistry and/or chemical engineering is preferred. The engineer should have familiarity with processing Silicone and PTFE.
Laser Processing Knowledge of (one or more) CO2, YAG, TEA, Excimer or Other types of lasers. This knowledge will be applied towards welding, of similar and dissimilar metals, plastics machining/ablation or other tasks to be defined.
Job Location
Chaska, Minnesota, United States
Position Type

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