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Manufacturing Process Engineering Leader
2 months ago
Job Overview:
This managerial role focuses on strategizing, directing, and executing initiatives aimed at enhancing manufacturing workflows for both existing and new products. The ultimate goal is to improve safety, quality, and efficiency, leading to superior product outcomes. This position includes oversight of team members, providing essential guidance and leadership.
Key Responsibilities:
- Ensure adherence to TMC Quality System standards concerning engineering and process control, including process controls, calibration, maintenance practices, and document control.
- Offer expertise and leadership to plan and execute projects aimed at developing, installing, and qualifying new manufacturing processes or refining existing ones to meet business objectives.
- Provide engineering insights in the design, fabrication, development, installation, and qualification of equipment, including conducting feasibility studies and ensuring proper documentation for project justification and training.
- Oversee the allocation and management of a team to support business needs, assessing resource availability and ensuring a suitable organizational structure and skill mix.
- Plan and troubleshoot improvements for production equipment.
- Foster a work environment that aligns with Terumo's compliance policies.
- Identify opportunities for cost reduction and conduct financial analyses for capital justification.
- Manage work schedules, budgetary expenditures, attend relevant meetings, and prepare necessary monthly reports.
- This role significantly influences product quality, company profitability, and operational capacity through project implementation and process enhancements.
- Engage in project performance meetings to contribute ideas and methods for improving unit and company performance.
- Coordinate with personnel from other departments to ensure project completion, providing guidance to direct reports throughout the project lifecycle.
- Execute additional job-related responsibilities as assigned.
Qualifications:
Knowledge, Skills, and Abilities (KSAs)
- Comprehensive understanding of statistical methodologies; DMAIC/six-sigma certification is advantageous.
- Proven analytical and problem-solving capabilities.
- Experience or certifications in Lean manufacturing practices are beneficial.
- Proficiency in experimental design and analysis for process development and optimization is required.
- Familiarity with GMP/FDA regulations and FDA process validations, including protocol development and execution.
- Experience in leading or participating in cross-functional teams for the launch of new medical devices.
- Expertise in Computer Aided Design, particularly Solidworks, is a plus.
- Strong verbal and written communication skills are essential.
- Ability to convey complex engineering issues to non-engineering personnel effectively.
- Thorough knowledge of laboratory testing and inspection equipment and tools.
Experience Requirements:
- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Polymer Science, Materials Science, or a related field; an advanced degree (MS/PhD) is preferred.
- A minimum of 8 years of experience in a manufacturing setting focused on major manufacturing and automation projects.
- At least 3 years of supervisory experience is required.
- Experience in the development and validation of catheter and medical device manufacturing processes (e.g., extrusion, lamination, injection molding, etc.) is advantageous.