Sr. Engineer, Production

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

• Improve manufacturing efficiency, production yields, product quality and consistency through equipment and process modifications and improvements.
• Developing, Implementing and maintaining manufacturing procedures using LEAN manufacturing methodologies based on product specifications.
• Responsible for processing ECO's.
• Analyzing and presenting data using statistical methods
• Developing and executing equipment and process qualifications (IQ, OQ, PQ).
• Assist technicians on equipment troubleshooting, updating and repair
• Act as manufacturing process SME to assist in investigations and root cause analysis to address nonconformance and CAPA's. Provide design input for medical device manufacturing equipment, tooling and fixtures.
• May serve as member on cross-functional project teams
• May provide work direction to other engineers, technicians and operators
• Analyzes and documents test results for development and pilot production runs.
• May serve as member on cross-functional project team

Minimum Requirements

• Bachelor's Degree in Mechanical, Industrial, Chemical, Biomedical, Plastics or other related types of engineering; advanced degree preferred
• Minimum of five years 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.

Supervision/Management Of Others:

• May provide work direction to other engineers, technicians and operators

Internal and External Contacts/Relationships

• Various internal and external contacts

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 work extended hours during peak business cycles

95k-120k with 10% STIP

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