Sr. Engineer, Process Development

Job Summary

Provide Engineering support to improve quality and efficiency for existing components. 
Determine critical component and supplier changes to support business needs. 
Lead and manage key process items to bring new components through the design phase into efficient manufacturing operations.  

Job Details/Responsibilities

• Monitor and improve the efficiency, output, and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.  
• Design advanced tooling and fixtures that will be used for the manufacturing and assembly of products
• Develop fixtures, jigs, and gages to assist with component inspection processes. 
• Document methods for inspection processes 
• Document evaluations into Engineering Notebooks 
• Design, evaluate, implement, and monitor processes and operating systems for the manufacture of aortic stent grafts. 
• Develop and implement new Mfg. processes, execute process validations such as IQ, OQ, PQ protocols and reports. 
• Support Quality system items such as CAPAs, NCRs, CQPs, TMVs, etc. 
• Create change requests within the company’s change management system.
• Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation
• Work with key suppliers to identify and develop improvements to ensure quality and cost requirements. 
• Responsible for component qualification activities and improvements.  
• Work with Research and Development to develop and transfer new component designs to manufacturing. 
• Perform statistical analyses on data groups.  
• Present data and projects to upper management when required. 
• Lead TMVs and software validation as necessary 
• Other various responsibilities and projects, as necessary  

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Quality Requirements:

• Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives
• Work within the QMS at all times, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality
• Responsible to ensure facility, processes and documentation remain in a state of audit readiness at all times

EH&S Requirements:

• Take care of your own health and safety and that of others who may be affected by your actions
• Work co-operatively to highlight issues affecting Environmental Health and Safety

Knowledge, Skills and Abilities (KSA)

• Knowledge of engineering statistics and advanced data analysis
• Strong technical writing skills for manufacturing instructions, test methods, protocols, reports, etc.is required
• Able to work closely with a variety of people and teams within the company.
• Ability to organize and conduct experiments independently.
• Ability to analyze and solve technical problems.
• Hands on abilities to engineer tooling, processes, and equipment.
• Hands on experience building prototypes, tooling, and fixtures.
• Excellent written and verbal communication skills
• Proficient in software applications 

Qualifications/ Background Experiences

• 4 - year engineering degree or equivalent experience
• 8+ years of experience in a technical role in the medical device industry
• Project management experience in the medical device industry
• Experience and understanding of quality system regulations (e.g. 21CFR820, ISO13485). 
• Project management experience in the medical device industry
• Experience with polymers, medical grade metals and medical packaging
• Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes