Job Description

ESSENTIAL JOB RESPONSIBILITIES:

* Responsible for driving assemblers engagement and for developing Lean and Six Sigma capabilities through coaching and mentoring.

* Responsible for performing process qualifications for new and existing production lines.

* Follow and observe all regulatory requirements (GMPs, ISO, FDA, internal policies) applicable to area of responsibility.

* Apply knowledge of relevant continuous improvement tools and approaches to increase production up-time, minimize unplanned maintenance, minimize work in process inventories (WIP) or plant inventories, and implement cost reduction initiatives across equipment and labor

* Assist in creating and updating manufacturing SOPs/Work Instructions.

* Provide training to Manufacturing personnel

* Seek and implement process improvements within Manufacturing

* Recognize machine operating conditions and requirements for optimum production runs and can troubleshoot and resolve basic line performance issues

* Identify constraints in, or non-conformances resulting from, the production process through analysis of material, people and information movement/flow

* Understand product cost drivers by interpreting product bill of materials and cost sheets to ensure adherence to projected cost

* Leverage knowledge of product costs and drivers and Design to Value concepts to effectively participate in cross-functional teams pursuing product cost improvement initiatives

* Effectively interface with other engineering disciplines, such as Controls & Automation engineering and New Product Introduction teams

* Develop and deliver oral and written communications around process improvement projects

* Organize an analytical approach to problem solving with familiarity with FDA and GMP

* Work within operating procedures to identify, change, justify, and implement process

* Utilize and leverage ongoing data and convert information into actionable procedures and reaction/escalation plans aligned with maintaining validated state of Class II and Class III automated equipment.

* Develop validation documentation for line extensions and process improvements and is the manufacturing liaison for all process qualifications.

* Partner effectively during root cause investigation through resolution with functional representatives of regulatory, automation, molding/tooling, production and quality.

* Facilitate communication of issues through an escalation process leveraging common templates and will consolidate and document root cause through resolution.

* In depth understanding of production and quality control techniques

TRAINING RESPONSIBILITIES:

* Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience (in years):

* Bachelors degree in Engineering or a related discipline; or equivalent combination of education and experience to perform at this level.

* A minimum of 5+ years overall related engineering experience within medical device or a regulated industry.

Knowledge and skills:

* Experience with Lean and Six Sigma - Experience with Project Management

* The ideal candidate should have experience with automation lines and developing process documentation.

* Must be able to work collaboratively in a matrix environment to implement solutions addressing problems associated with commercial production.

* In depth understanding of production and quality control techniques (such as CFM and TQM).

* Understanding of financial processes (standard cost development) and business planning.

* Strong analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems

* Experience with failure investigations, root cause failure analysis, process engineering, etc.

* Fluent in the use of MS Excel for data analysis and presentation in graphic formats

* Solid mathematical skills with basic statistics knowledge

* Working knowledge of design of experiments and interpretation of test results

* Excellent communication skills. Must be able to communicate verbally in an efficient and effective manner and be proficient in document preparation and editing, including detailed test planning and report writing. Must be able to reduce data to coherent form for clear presentation.

* Must have ability to meet deadlines on multiple concurrent projects

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.