Lead Manufacturing Engineer
2 weeks ago
Position Summary:
The Senior Manufacturing Engineer is pivotal in driving daily operations concerning products, processes, materials, and machinery. This role encompasses overseeing the integration of new products into production while ensuring adherence to timelines and production objectives, including safety, quality, delivery, cost, and efficiency. The individual will collaborate extensively with cross-functional teams to assess, troubleshoot, and enhance manufacturing processes within the organization.
Key Responsibilities:
- Collaborate effectively with R&D, Process Development, Quality Assurance, Production, Regulatory Affairs, Equipment Engineering, Supply Chain, and Marketing on intricate projects to guarantee successful outcomes.
- Innovate and devise unique solutions to complex challenges that align with departmental objectives.
- Execute sophisticated engineering tasks and contribute to new product development initiatives, which may involve technology advancement, material testing, specification preparation, Six Sigma methodologies, process analysis, enhancements, and report generation.
- Ensure that newly introduced products to the production environment meet business standards, quality benchmarks, output targets, and cost objectives.
- Select appropriate process improvement methodologies to address technical challenges and provide sound recommendations regarding equipment and processes, demonstrating a comprehensive understanding of various alternatives and their implications for the business unit.
- Design and oversee relevant engineering tests and experiments.
- Analyze and interpret complex test results, drawing insightful conclusions.
- Prepare engineering reports and effectively communicate findings to both technical and leadership audiences.
- Manage project goals and progress, documenting updates and suggesting necessary adjustments.
- Evaluate the feasibility and reliability of proposed engineering tests, products, or equipment.
- Oversee and manage Capital Equipment Request Authorizations (CERA's).
- Lead cross-functional project teams to achieve strategic objectives.
- Contribute to the identification, implementation, and management of Business Unit goals, actively participating in the formulation of the Business Unit's long-term strategy.
- Provide training and mentorship to team members, including engineers, technicians, and product builders, fostering the development of junior staff through exemplary guidance and support.
- Commit to patient safety and product quality by adhering to the Quality Policy and all established quality processes and procedures.
Required Qualifications:
- Bachelor's Degree in an Engineering discipline.
- 5+ years of experience in manufacturing, process, or related engineering fields.
- Proven experience in resolving advanced technical issues.
- Experience in qualifying complex machinery.
- Familiarity with lean manufacturing principles.
- Ability to manage multiple projects concurrently.
- Strong inclination towards action and the capacity to prioritize effectively in a dynamic environment.
- Experience with manufacturing problem-solving and process improvement tools, including DMAIC and lean methodologies.
- Proficiency in data analysis and statistical tools such as Minitab.
- Willingness to travel up to 5% of the time.
Preferred Qualifications:
- Master's Degree.
- Experience in medical device manufacturing technologies, including but not limited to: shape forming of metals and plastics, laser welding, ultrasonic welding, adhesives, injection molding, laser marking, inkjet printing, laser cutting, pad printing, and sterile barrier sealing.
- Basic understanding of automation, PLC programming (Allen-Bradley), and machine vision systems (Cognex & Keyence).
- Familiarity with 3D modeling software such as Solidworks.
- Basic knowledge of business intelligence tools like PowerBI and Tableau.
- Experience with PTC Windchill Product Lifecycle Management software or similar platforms.
- Demonstrated ability to communicate effectively with various stakeholders at different organizational levels, as well as with suppliers and equipment vendors, fostering a continuous improvement mindset.
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