Manufacturing Engineer, Medical Device

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

The Manufacturing Engineer provides guidance and support of manufacturing methods, tooling, equipment, test systems, and documentation to ensure effective medical device manufacturing and to promote continuous improvement.

Responsibilities will include:

• Provide strategic direction and leadership to manufacturing teams, implementing standardized processes across operations to enhance safety, quality, and efficiency.

• Offer technical leadership and collaborate with various departments to develop robust manufacturing processes, prioritizing project completion timelines.

• Manage projects aimed at improving first pass yield and cycle time in manufacturing.

• Lead technical support efforts for medical device manufacturing activities.

• Provide leadership and guidance to production associates, troubleshoot unusual conditions, and collaborate cross-functionally to achieve project objectives in a timely manner.

• Ensures compliance with the company quality system, in accordance with the applicable Code of Federal Regulations, ISO 13485, customer and company requirements.

Essential Functions

• Support all manufacturing methods, tooling, preventive maintenance, equipment calibration, test systems, and documentation ensuring compliance with company quality system and regulatory requirements.

• Develop and revise Standard Operating Procedures (SOP), Work Instructions (WI), Device History Records, Validation Master Plans, Process Flow Diagrams or other quality documentation, as necessary, to support production processes.

• Train Production Associates on new and/or revised production processes, equipment, and documentation.

• Work closely with Production Associates to improve production processes, improve first pass yield, and design for manufacturability in a timely manner.

• Effectively support production associates with medical device manufacturing day-to-day challenges.

• Troubleshoot devices and/or components rejected by regional service centers; documents findings, compiles associated data and metrics, feeds findings into product continuous improvement cycle.

• Manufacturing process subject matter expert for medical device Manufacturing Team, Materials Team, Global Device Engineering, QA, and Service Operations.

• Collaborate with engineering and quality in problem solving activities applying statistical techniques/analysis where applicable.

• Work with device manufacturing team, materials team, R&D, QA, and Technical Operations management to effectively troubleshoot equipment and process issues.

• Serve as engineering resource for material review board, supplier selection team and supplier development team.

Minimum Requirements

• Associate's degree in electrical or mechanical engineering (a combination of experience, education and training may suffice in lieu of formal education)

• 3+ years' experience in manufacturing technical support; project or team leadership experience, preferably in a medical device manufacturing environment.

• Ability to manage an increasing number of projects and/or projects of increased complexity and to complete routine projects independently.

• Strong interpersonal skills, good technical communications with an ability to communicate effectively with other departments.

• Excellent time management/organizational skills and ability to work independently

• Proven ability to manage competing demands in a fast-paced and dynamic work environment.

• Willingness to work scheduled/expanded shifts, holidays and/or off-shift duties, as necessary

Preferences:

• Experience with SAP and LabView software

• Experience with Lean Six Sigma methodologies and Green Belt Certification

Organizational Relationship/Scope:

The Manufacturing Engineer reports to the Manufacturing Engineering/Facilities Manager. This role interacts cross functionally across the various device development and manufacturing areas with primary emphasis on manufacturing techniques and processes while maintaining appropriate process controls and methods. This role is also accountable for new product introduction to manufacturing as a part of product realization.

Working Conditions:

The role of the Manufacturing Engineer is primarily a support role within the operations department. Work will be split between manufacturing line support, office/computer work, attending meetings, preparing presentations, and interfacing with other departments.

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