INGENYX- Staff Engineer

Position Summary

The Staff Engineer will lead high level engineering efforts to develop and improve products, manufacturing processes, equipment and systems by application of high-level engineering skills, structured experimentation and process optimization techniques. This role will provide engineering leadership in terms of long-term technology development and will lead the alignment of our capabilities with the existing and future user needs of our customers.

Principal Responsibilities

•    Coach, develop, manage and motivate staff to ensure that employees achieve their full potential.
•    In conjunction with the Engineering Manager, develop and cascade departmental long term and short term business objectives, in line with business needs.
•    This role will principally focus on further developing our fluoropolymer extrusion capability and deepening our understanding of this process.
•    Take a hands-on approach to process improvement based on a deep understanding of the existing process tacit knowledge. Use of structured experimentation techniques and process optimization techniques to deepen the site’s process understanding and provide a solid engineering framework to manage and refine these processes in the long term.
•    Apply six sigma principles, lean thinking, and continuous improvement tools where they are appropriate to improve process performance.
•    Lead and oversee major projects in a matrix organization as a team leader, whose duty encompasses the full scope of the project
•    Independently plan and technically lead a program of projects utilizing project plans and schedules to track and communicate developments from prototype stage to volume production. 
•    Support successful new product development by developing fully  characterizing and implementing strong robust manufacturing processes. 
•    Communicate and liaise directly with customers during the development stage of development projects in line with site requirements
•    Drive refinement and updating of process PFMEA’s in order to better capture and record the site’s tacit knowledge in relation to core manufacturing processes.
•    Develop systems which efficiently leverage existing process characterizations and validations knowledge for new product introductions.  
•    Develop systems to demonstrate and achieve equipment equivalency on all core processes so process validations can be leveraged across the equipment stock. 
•    Develop active plant wide map of equipment that is equivalent for validation purposes.
•    Identify opportunities and implement changes to reduce variation and improve scrap rates and productivity often through the implementation of new technology or more refined process controls.
•    Stay current with cutting-edge medical device industry and technology trends to help ensure the site is constantly evolving to better meet customer needs.
•    Take total ownership for area of responsibility. This can be interpreted as taking a proactive approach to improvement and anticipating, recognizing, and dealing with problems before they become major issues. 
•    Direct and mentor the efforts of engineers, engineering specialists and engineering technicians in the development of products, processes, specification of equipment and creation of documentation to support process development, characterizing and qualification. 
•    Generate and evaluate alternatives, analyze data, reach logical conclusions, formulate recommendations, and institute effective changes.
•    Execute and complete improvement projects that improve quality, increase capacity, reduce scrap, or reduce cost
•    Lead process improvement with emphasis on the fluoropolymer extrusion processes with the goal of driving long term sales growth.
•    Ensure full compliance with regulatory requirements.
•    Ensure Quality and EHS policies and procedures are adhered to at all times.

Education / Experience Requirements

•    Bachelor's level degree in Engineering or equivalent with deep experience in process development, optimization, and refinement. 
•    MS degree in an engineering field preferred.
•    Fifteen (15) or more years of relevant experience in engineering field related to manufacturing in a medical device environment.
•    Prior experience with extrusion processes a distinct advantage 
•    Proficient in Microsoft Office Suite and computerized analysis applications.  

Specialized Skills / Other Requirements

•    Deep understanding of the theoretical operating principles of core manufacturing and metrology processes allied with expert practical knowledge of them.
•    Proven track record of performing process characterizations and validations on numerous core processes used in medical device manufacturing. 
•    Statistical analysis
•    Strong materials background 
•    Strong manufacturing process knowledge. 
•    Structured Problem Solving techniques
•    Understanding of Lean Principles
•    Ability to drive projects to completion
•    Understanding of new product introduction process
•    Understanding of Design Control and the specific outputs at each phase
•    Technical report writing 
•    Process validations/FMEA's and protocols
•    Understanding of Health & Safety - Machine safety, basic Ergonomics, electrical safety, Chemical safety 
•    Ability to influence employees that do not report directly
•    Understanding of costs management & control
•    Understanding of Finance - Profit and loss and balance sheet

COMPETENCY PROFILE

People
•    Ability to manage the performance of others.
•    Facilitate and encourage employee development
•    Ability to lead meetings.
•    Ability to work in a cross functional team
•    Clear verbal and written communication, and “follow through on communication” to ensure key messages are understood. 
•    Ability to coach and mentor others, including directly mentoring the efforts of engineers.
•    Ability to translate complex technical detail into clear and understandable training content
•    Ability to communicate technical content in a clear and concise manner 
•    Ability to strategically analyze and address training gaps in a systematic manner that ensures tacit knowledge is captured in a formal way
•    Ability to use interpersonal skills to deal successfully with day to day people related issues
•    Qualities and Principles of Genuine Leadership

Strategy
•    Understand the key drivers impacting the business.
•    Strategically develop standard equipment and process qualifications platforms which allow existing qualifications to be levered and effectively reduce the qualification burden for new equipment and products.
•    Ability to contribute to and to generate strategic business plans based on key business drivers.  
•    Ability to cascade business plans to actionable departmental projects and tasks.
•    Ability to manage performance proactively to ensure the business plans are achieved.

Customers and Vendors
•    Ability to communicate technical information and concepts to customers in a clear format.
•    Strong fact based communication style
•    Ability to prepare detailed project proposals for prospective opportunities
•    Ability to deal with difficult customer and vendor communications
•    Ability to influence customers where necessary
•    Ability to understand customer relationships
•    Ability to generate appropriate relationships with customers
•    Understanding of the need to balance customer requirements with Ingenyx business needs.

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