A large medical device client/employer of Insight Global is searching for a Manufacturing Engineer to join their operations team. This person will assist with designing, developing, and maintaining systems and processes for the client's medical devices.

Responsibilities may include:
- Management and Technical Expertise: Responsible for managing manufacturing activities and technical operations. Serves as a technical subject matter expert (SME) for all medical device products.
- Collaboration with New Product Development: Collaborates with new product development teams to ensure successful integration of new products into manufacturing processes.
- External Support and Training: Visits external manufacturing sites as needed to provide technical and validation support and training to contract manufacturing organizations.
- Documentation and Compliance: Creates and maintains technical product specifications, standard work, drawings, bill of materials, batch records, procedures, and Global Unique Device Identification Database (GUDID).
- Process Improvements and Design Controls: Leads development, troubleshooting, and manufacturing process improvements with external vendors. Prepares design controls and design transfer.
- Packaging and Quality Standards: Develops product packaging and establishes test requirements per ISO and ASTM standards.
- Lean Principles and Efficiency: Uses Lean principles to identify and implement processes that reduce waste and improve manufacturing yield and throughput.
- Equipment Design and Validation: Serves as an SME for designing, assembling, modifying, and supporting custom-designed and off-the-shelf processing equipment.
- Process Validation and SOPs: Manages process validation/verification and equipment qualification activities. Develops standard operating procedures (SOPs) to ensure best practices are consistently followed.
- Issue Resolution and Performance Goals: Identifies and resolves process/service issues, analyzes data to determine root cause, and implements corrective actions. Measures assigned performance goals for manufacturing operations.
- Ethical Conduct and Risk Management: Collaborates with Audit & Risk Management function to identify business risks and develop preventive strategies.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Required Skills & Experience
- Bachelor's Degree in Engineering
- 2+ years of experience
- Medical device background
- Strong communication and problem resolution skills
- Knowledge of state regulations and requirements for surgical products
- Experience with lean concepts
- Proficiency in Microsoft Office

Nice to Have Skills & Experience
- Green Belt certification
- SAP knowledge
- Degree in Mechanical or Industrial Engineering

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.