Job Description

Overview:

Do you have the desire to join us in a collaborative environment at the largest manufacturing hub in North America? Change the direction of your career at our Regional Technical Headquarters. In this role the engineer applies engineering knowledge to plan, develop, validate, and test manufacturing processes to meet FDA and ISO requirements. Uses knowledge and skill to qualify parts, equipment, fixtures, test plans to guarantee adherence to customer and regulatory requirements.

THIS POSITION FEATURES AN EXCEPTIONAL SIGN-ON BONUS!

 Responsibilities:

• Review criteria with potential suppliers and support the development of quotes for parts, fixtures, and equipment.
• Coordinate equipment installations with Facilities and/or manufacturing departments.
• Monitor the status of projects including equipment and process qualifications, change orders, and product launches.
• Establish project plans and provide feedback to appropriate personnel.
• Analyze production data to identify trends and develop appropriate action items.
• Lead customer and supplier technical communications.
• Research sources for domestic and international parts.
• Participate / create Design of Experiments and test method validations (Gage R&R).
• Interpret customer requirements using engineering experience to develop production and equipment specifications.
• Support creation of Master Validation Plans (MVP) for product transfers.
• Develop and execute IQ, OQ, and PQ plans to qualify production processes, equipment, and fixtures.
• Conduct part and process investigations related to non-conforming part or process failures.
• Perform root cause analysis and issue change requests as needed to implement countermeasures and improvements.
• Design fixtures and tools to meet customer specifications.
• Create and implement production processes and project requirements including design of automation equipment, in-struments, controls, machines, and mechanical/ electrical systems.
• Responsible for appropriately documenting all process designs and all product transfer activities.
• Issue change orders, corrective and preventative actions, technical reports and memos.
• Develop critical to quality and/or critical to process items for parts and processes.
• Coordinate and perform risk assessments using standard tools (pFMEA, Fault Tree, Fishbone)

 Qualifications:

• Bachelor’s degree in Engineering or related field and 2-5 years’ experience in a manufacturing environment or related field.
• Proficient in Microsoft Office.
• Strong written and verbal communication skills.
• Ability to create and verbally deliver presentations to internal management and other audiences.
• Requires analytical, problem solving and project management skills. Experience in medical industry or equivalent regulated industries. Experience with CAD (Solidworks, Inventor) required.
• Experience with molding, industrial automation recommended.
• Experience with aspects of design for manufacturing recommended.
• Experience with working with suppliers of machined, stamped, molded, die-cut components recommended.
• Experience with electronic quality management system (EQMS) a plus.
• Experience with technical report writing and familiarity with GD&T
• May have to work overtime and may be assigned to other shifts based on company needs.

Job Categories: Engineering And Architecture. Job Types: Full-Time. Salaries: 80,000 - 100,000.

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