Product Sustaining Engineer 3 - Product

Essential Duties & Responsibilities

• Support initiatives for continuous process and product improvements
• Work to improve performance of manufacturing systems, e.g. yield, cycle-time, quality requirements, maintenance’s needs
• Support project timelines and milestones and bring them to completion on time and within budget
• Assist in completion of CAPA tasks and deliverables (Corrective and Preventive)
• Identify and qualify “end-of-life” components.
• Represent Sustaining Engineering to identify possible product modifications to improve manufacturability and impact on production processes.
• Initiate and manage projects with adherence to program management guidelines
• Coordinate efforts with the Materials Group to assess vendors and provide materials technical information
• Conducts independent analysis and develops solutions to problems.
• Develops approaches and designs where precedent usually exists.
• Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design.  
• Writes detailed design specifications.
• Assists in training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
• Work on special projects as they arise

Knowledge, Skills & Qualifications

• Understanding of strength of materials, automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques
• Knowledge of Solidworks to interpret part dimensions, sectional views, conduct mates, build assemblies.
• Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) - use of Minitab Software for analysis
• Knowledge of the Medical Device Industry and familiarity with FDA QSR Regulations is a plus
• Competent in your domain.  Familiar with other areas of domain expertise within the team.
• Has a basic understanding of best practices. Has a basic to intermediate understanding of engineering discipline
• Have awareness of the broader product strategy and contribute to it
• Ability to receive general project direction and solicit input from more experienced engineers.
• Requires the ability to independently make decisions that impact the attainment of project 

Minimum Qualifications

• Must be at least 18 years of age

Minimum Qualifications, Education & Experience 

• Must be at least 18 years of age
• Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field. Master's Degree preferred. 
• 4+ years of experience in Medical Device Product Development or related field

Work Environment

• This is largely a sedentary role. 
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of the time