Job Summary:
Plans, directs, and implements projects that improve manufacturing processes for existing products or support new-product development, directly influencing safety, quality, capacity, productivity, and cost. Leads and develops a team of associates and provides the oversight, guidance, technical expertise, and resource management needed to achieve business objectives.
Job Details
Main Responsibilities:
Direct compliance with the TMC Quality System and applicable engineering and process-control requirements, including process controls, calibration, maintenance, document and data control, and change control.15%Plan and implement projects to develop, install, and qualify manufacturing processes for new products and improve existing processes in support of business-plan objectives.20%Provide engineering leadership for the design, fabrication, development, installation, and qualification of equipment, including feasibility studies, project justification, documentation, and operator training.15%Manage team workload, deployment, organizational structure, and skill and experience mix by evaluating resource supply against business demand.15%Lead project improvements and troubleshooting for production equipment and coordinate cross-functional personnel and direct reports through project completion.15%Identify cost-reduction opportunities, conduct financial and capital-justification analyses, and manage work schedules, expenditures, meetings, and monthly reporting.10%Promote compliance with company policies, participate in performance-improvement teams, contribute ideas and processes for company improvement, and perform other assigned duties.10%Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large. Organizational Impact: Has broad impact on product quality, patient and associate safety, company profitability, manufacturing capacity, and productivity through process changes, automation and equipment projects, capital expenditures, and team performance. Communication & Influence:leads engineering associates and collaborates with Manufacturing, Quality, project teams, management, and other departments. Explains complex engineering issues to technical and nontechnical stakeholders and communicates priorities, resource needs, project status, financial justification, and improvement recommendations. Innovation & Complexity: Directs complex manufacturing-process, equipment, automation, validation, and troubleshooting activities that require analysis of safety, quality, capacity, cost, technical feasibility, and regulatory requirements. Uses statistical, experimental-design, Lean, and engineering methods to develop and qualify effective solutions. Leadership & Autonomy: Directly manages a team of associates and is accountable for supervision, guidance, development, workload deployment, organizational structure, and delivery of departmental and project objectives. Exercises managerial judgment over resources, schedules, expenditures, capital recommendations, and compliant execution. Organizational Chart: Reports to Sr. Manager/Director/VP, Engineering. Direct and indirect report counts were not provided in the source job description and are to be confirmed.
Position Requirements
Knowledge, Skills and Abilities:- (KSAs):Thorough knowledge of statistical techniques; DMAIC or Six Sigma certification is preferred.
- Excellent analytical and problem-solving skills and experience with experimental design and analysis for process development, characterization, and optimization.
- Knowledge of GMP and FDA regulations and FDA process-validation requirements, including protocol development and execution.
- Experience leading or participating in cross-functional teams from concept through launch of new medical devices.
- Knowledge of Lean manufacturing techniques; relevant training or certification is a plus.
- Thorough knowledge of laboratory testing equipment, tools, and inspection systems.
- Excellent written and verbal communication skills, including the ability to explain complex engineering problems to non-engineering personnel.
- Computer-aided design expertise, particularly SolidWorks, is a plus.
- Background Experiences:
- Bachelor of Science degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Polymer Science, Materials Science, or a related field; an advanced degree (MS or PhD) is preferred.
- Minimum of eight years of experience in a manufacturing environment implementing major manufacturing and automation projects.
- Minimum of three years of supervisory experience.
- Experience developing and validating catheter and medical-device manufacturing processes, such as extrusion, lamination, injection molding, tipping, shaping, and bonding, is a plus.
