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Sr. Manufacturing Engineer
Job Opportunity at
Professional Partners Group
Posted on Jan 5
Job Summary: Position is responsible for a variety of project-based functions, all of which are related to the Manufacturing, Compliance and Design of Products.
Project Engineering role in product commercialization, coordinating component manufacturing and assembly process development.
Support validation of all manufacturing processes per FDA requirements for medical device development.
Implement production control methods to monitor process output and establish critical supplier metrics.
Define and coordinate the design and development of manufacturing fixturing and test equipment, including MSA and Gage R&R.
Perform or direct DOE, correlation studies and apply statistical analysis for process and product improvements.
Define runoff requirements, and conduct capability, stability, first article inspection and other statistical analysis as required.
Conduct D/PFMEA to evaluate potential failures and implement mitigations.
Insure compliance to the requirements of ISO13485 standards, FDA regulations and Good Manufacturing Processes.
Provide continuing product support for manufacturing, sales and quality on design requirements, customer needs, testing, CAPA and product documentation.
Create and maintain product assembly instructions.
Create and maintain BOM and Routings.
Must be action-oriented with demonstrated customer focus and problem solving skills and enjoy working in a dynamic work environment with a focus on technical excellence, customer responsiveness
and creative thinking.
• Able to adapt to shifting priorities, handle a rapid pace environment, and to resolve problems / conflicts.
• Must have good interpersonal skills, be able to coordinate and resolve technical problems and work well in teams, be a pragmatic problem-solver, be organized, efficient and have excellent attention to detail and drive to follow-through for completeness.
• Have a passion for your work and a sincere interest to improve patient outcomes.
• Direct, Support and mentor Jr. Level Engineering Staff.
• Must have experience in manufacturing and assembly process development and validation (IQ, OQ, PQ and PPQ)
• Mechanical or electro-mechanical manufacturing experience in the medical device industry
• Experience with sterilization and sterilization validation, experience with packaging development and packaging validation, experience with cannula/needle manufacturing and handling, experience with plastic injection molding of medical products, formal Six Sigma or lean training and working experience.
• Bachelor’s Degree in Mechanical Engineering or other relevant Engineering discipline. 8-10 years relevant work experience may be considered in lieu of Bachelor's Degree.
• Understanding and experience in product design phases leading to commercialization including the use of tools such as DFMEA, PFMEA, and Risk Analysis.
• Robust understanding of process validation concepts and practices including, IQ, OQ, PQ and PPQ.
• Knows and applies fundamental concepts, practices and procedures of a variety of manufacturing practices including lean manufacturing.
• Understanding and application of ISO Quality System requirements and FDA regulations.
• Excellent project management skills. Microsoft Project or Project Management Tools required.
• Technical ability to interface with suppliers using CAD models including other technical information.
• Superior verbal and written communication skills.
• Strong Statistical Knowledge and experience with Root cause analysis (DOE, Regression, KT, 8D, Hypothesis testing, etc.)
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Position requires sitting for prolonged periods as well as stand for periods of time.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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