Process development engineer h1.location_city

Years Experience : +

Skills : Experience working in a broader enterprise / cross-division business unit model work within a team, individual contributor, multitasks, ability to prioritize, strong written and verbal communication, strong organizational skills, attention to detail, results driven

Education : Bachelor of Science in Engineering or Technical Field, an equivalent combination of education and work experience

Duties : 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 ( 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 ( 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 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 ( 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 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

• 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 Sigma Green or Black Belt certification

EEO :