Senior Engineer, Process Engineering - Individual Contrib...

We are offering a contract to permanent employment opportunity for a Senior Engineer, Process Engineering in the Medical Devices industry based in Portage, Michigan, United States. The role involves a blend of technical expertise and project management, with a focus on PLC programming and validation work within a complex network of stakeholders.

• Provide engineering support for product transfers, ensuring all activities are completed and documented in compliance with the latest procedures.
• Determine the technical objectives of engineering assignments and make decisions that guide the direction and results of the assignment.
• Monitor and control progress of work, ensuring the sound application of engineering principles and appropriate use of policies and procedures.
• Analyze equipment to establish operating data, conduct experimental tests, and analyze results.
• May lead or act as an independent reviewer in process review meetings.
• Coach and mentor others on functionally related topics.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Select components and equipment based on analysis of specifications, reliability, and regulatory requirements.
• Work with quality engineers to develop component-specific testing and inspection protocols.
• Participate in the generation of internal process qualifications associated with product transfers, such as PFMEA, Control Plan, SOP, PPAP.
• Ensure adherence to safety procedures.
• Review and approve of validation documentation.
• Perform all other duties as assigned. • Must have strong management skills to oversee operations and project execution
• Proficient in creating and maintaining documentation related to system design, policies, and procedures
• Ability to plan, coordinate, and execute complex engineering projects
• Familiar with payroll systems and process in a large organization
• Demonstrated experience in quality review and assurance processes
• Exceptional design skills, especially in the context of process engineering in the medical devices industry
• Ability to troubleshoot issues, identify root causes and implement corrective actions
• Strong understanding of engineering principles and ability to apply them in a practical setting
• Excellent communication skills, both verbal and written, for effective interaction with stakeholders and partners
• Ability to collaborate effectively with cross-functional teams to achieve project objectives
• Proven experience in process improvement and optimization in a manufacturing environment
• Familiarity with component selection and specification in the context of medical devices
• Experience in developing and following engineering protocols
• Ability to prioritize tasks effectively to meet project timelines and quality standards.