Engineer II, Production (Onsite) - Merrimack, NH

Job Overview

Provides daily Manufacturing Engineering support to medical device manufacturing lines. Monitoring and analysis of production yields and production process capability. Collaborating with quality engineering on the investigation, root cause analysis and resolution of nonconformances, customer complaints and CAPA’s. Identify areas of cost improvement, manufacturing efficiencies optimization, and cGMP gaps within the manufacturing area.

Job Responsibilities and Essential Duties

• Provide engineering support to production on a daily basis
• Assist with equipment and process qualifications (IQ, OQ, PQ).
• Execute and facilitate Engineering builds for DOE’s
• Responsible for processing ECO’s.
• Support quality in the investigations and root cause analysis of manufacturing nonconformance’s
• Develop and implement corrective actions related to nonconformance’s and CAPA’s
• Assist technicians on equipment troubleshooting and repair
• Analyzing and presenting data using statistical methods
• Developing, Implementing and maintaining manufacturing procedures using LEAN manufacturing methodologies based on product specifications.
• May serve as member on cross-functional project teams

Minimum Requirements

• Bachelor’s Degree in Mechanical, Industrial, Chemical, Biomedical, Plastics or other related types of engineering; advanced degree preferred
• Two to Five years engineering related manufacturing experience (medical device field is preferred).
• Knowledge statistics and SPC methods preferred.
• Knowledge of FDA Code of Federal Regulations 21 and ISO standards preferred. 
• SolidWorks and Minitab experience highly desired. 
• Strong computer skills, including MS Office applications (Word/Excel). 

Required Knowledge, Skills and Abilities

• Demonstrated analytical and problem solving skills utilizing statistical software (minitab, JMP, ect). 
• Experience in process improvement, new product development, equipment / process validation and engineering study development. 
• Effective communication skills both verbal and written. 
• Ability to function as part of a team, and accomplish assigned tasks independently. 
• The ability to be flexible while maintaining a positive attitude.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May be asked to work extended hours on occasion
• Position requires on site attendance. Remote working may be accommodated on an occasional basis
• Travel: Less than 10%