Senior Development Process Engineer

The Fountain Group LLC

St. Paul, MN

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JOB DETAILS

SKILLS

Analysis Skills, Coaching, Communication Skills, Corporate Policies, Cost Control, Cost of Goods Sold (COGS), Cross-Functional, Debugging Tools, Detail Oriented, Documentation, Engineering, Environmental Issues, Environmental Management Systems, Experiment Design, FDA (Food and Drug Administration), FDA Requirements, Finance, Follow Through, IP (Internet Protocol), Lean Manufacturing, Lean Six Sigma, Machine Tool, Maintain Compliance, Manufacturing, Manufacturing Design, Manufacturing Engineering, Mechanical Engineering, Medical Equipment, Mentoring, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, OSHA, Operations Processes, Organizational Skills, People Management, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Engineering, Process Improvement, Process Validation, Product Support, Product/Service Launch, Productivity Management, Project/Program Management, Purchasing/Procurement, Quality Control, Quality Management, Regulations, Regulatory Requirements, Research & Development (R&D), Root Cause Analysis, Six Sigma Black Belt, Six Sigma DMAIC, Six Sigma Green Belt, Team Lead/Manager, Test Equipment, United States Department of Energy (DOE), Writing Skills

LOCATION

St. Paul, MN

POSTED

4 days ago

Establish processes based on product specifications, evaluate process and design alternatives based on Design for Manufacturability principles, understand principles of Cost of Goods Sold, manage program compliance with Quality Control requirements (i.e. Design Control, Process validation etc.), understand IP issues relative to processes being developed, maintain knowledge of new developments in manufacturing and design technologies, understand work environment issues (i.e. OSHA regulations, etc.), support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements, Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Primary Responsibilities:

Run design of experiments (DOE) studies to characterize processes to improve yield and efficiency
Coach, mentor, and provide guidance to technicians, trainers, and operators
Manage projects which include new production equipment, process development/improvements and cost reductions while supporting new product introductions
Conduct equipment qualifications and process validations
Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts and root cause investigation tools (e.g. DMAIC)
Coordinate the design, procurement, build, and debug of tooling, machinery, and test equipment
Work cross functionally with R&D, Finance, Quality and Operations to define process inputs and outputs
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications:

Bachelor’s Degree in Chemical, Industrial, or Mechanical Engineering, or other related discipline
5+ years manufacturing engineering experience in medical device or related industry, including working on and documenting process improvement initiatives
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Previous experience working in a highly matrixed and geographically diverse business environment
Strong analytical, problem solving, and project management skills
Strong organizational and follow-up skills, as well as attention to detail
Individual should be innovative, resourceful, and work with minimal direction
Individual should have excellent organization, problem solving, communication, and team leadership skills
Proficient with MS Office (Word, Excel, Outlook, PowerPoint)

Preferred Qualifications:

Medical device experience
Previous close interface with R&D preferred
Previous delivery system experience in design and driving yield improvements, reducing cost, while increasing capacity
Lean 6 Sigma Green or Black Belt certification

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About the Company

The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE

500 to 999 employees

INDUSTRY

Staffing/Employment Agencies

WEBSITE

https://www.thefountaingroup.com/

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