Summary

Assisting in the development, qualification and execution of medical device and industrial manufacturing. Responsible for supporting the Production Services Operations Team with engineering programs, procedures, and systems that deliver products that consistently meet or exceed customer, regulatory, and company requirements; improve current manufacturing processes and procedures; develop manufacturing plans and documentation to support new products; facilitate efficient operations within the production area to ensure production goals are met; analyze and solve problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems.

Essential Duties And Responsibilities

• Assist in the development and qualification of Medical Device and Industrial productions
• Write detailed production documentation
• Evaluate manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators
• Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors
• Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout
• Assure product and process quality by designing testing methods; testing finished goods, determining product and process capabilities; establishing standards; confirming manufacturing processes.
• Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements
• Prepare product and process reports by collecting, analyzing, and summarizing information and trends
• Provide manufacturing engineering information by answering questions and requests.
• Maintain product and company reputation by complying with FDA, ISO9001 and ISO13485 regulations
• Keep equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
• Contribute to team efforts by accomplishing related results as needed
• Develop statistical methods of quality control.
• Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions
• Support validation in all manufacturing processes per FDA requirements for medical equipment
• Conduct risk assessment on process steps and their ability to meet requirements
• Create and maintain product assembly instructions
• Establish preventive maintenance and calibration requirements for process fixturing / equipment
• Identify opportunities for cost reduction; implement process and product improvements to achieve cost reduction goals
• Ensure proper documentation is completed to meet quality systems requirements. Write and review validation protocols and reports applicable to new processes
  
  

Other Duties And Responsibilities

• Safely perform duties following quality standards
• Participate in team building, training and department communications
• Work as a team player with management and co-workers to develop a win-win partnership through positive relationships and excellent interpersonal skills
• Maintain a commitment to our vision and “spirit” by partnering with new and current employees by demonstrating outstanding service and integrity
• The goal of each team member - and the team as a whole - is to create effective communications that help all employees clearly understand overall company objectives and the role they play in helping us meet those objectives
• Other duties may be assigned
  
  

Qualifications

Minimum of Bachelors Degree in Manufacturing Engineering or other relevant Engineering discipline. To perform this job successfully, the 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.

• Dealing with Complexity, Informing Others, Leadership, Supervision, Hardware Specifications, Manufacturing Methods and Procedures, Manufacturing Quality, Product Development, and Presenting Technical Information.
• Knows and applies fundamental concepts, practices and procedures of a variety of manufacturing practices including lean manufacturing. (manufacturing cost structures, cycle time studies, line balancing, level loading, constraint management, labor and equipment capacity analyses, value stream mapping, SMED among others)
• Robust understanding of process validation concepts and practices including, IQ, DOE, OQ, PQ and PPQ
• Basic understanding of ISO Quality System requirements and FDA regulations
• Adept and experienced problem solver able to determine root cause of technical issues and implement effective solutions in a timely manner
• Creative thinker with ability to think ‘out of the box’ in a fast-paced entrepreneurial environment
• Demonstrated resourcefulness and ability to adapt to a variety of situations
• Demonstrated ability to prioritize, initiate, and drive projects to completion
• Solid knowledge of engineering fundamentals; ability to apply this knowledge to manufacturing and product
• Strong attention to detail
• Must be well organized.
• Must have strong documentation skills
• Must have complete working knowledge of MS Office.
• Must have a good understanding of statistics
• Must have basic mechanical design skills.
• Must have good written and verbal communication skills.
• Some light travel may be required.
  
  

EDUCATION And/or EXPERIENCE

Typically requires a University Degree with 4-7 of relevant experience or an Advanced degree with a minimum of 2 years relevant experience.