Empleos de solesis

Who we are:

Solesis is an innovative provider of biomaterials solutions and services primarily focused on the MedTech and Biopharma industries.

About the role:

The Manufacturing Engineer focuses on expanding manufacturing and technology capabilities, improving existing textile and related manufacturing systems, enabling the introduction of new products, and providing project management support for various departments throughout the company.

What you will do:

• Evaluates, and improves manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards.
• Develops new manufacturing methods using existing or new equipment to ensure repeatability and conformance to customer specifications.
• Develops processes for manufacturing products using Lean, Six Sigma, and/or Statistics based methods and principles for process excellence
• Monitors and audits the performance of processes and equipment and makes recommendations for continuous improvement.
• Confers with vendors and internal resources to determine product specifications and arrange for purchase and installation of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
• Maintains control of system software’s, control logic program files, mechanical and electrical schematics, drawings and bills of materials and revision histories.
• Document processes and train operators and other personnel.
• Interact with Product Development to ensure manufacturability or minimize the risks associated with new products transferred to the Commercial Business Group.
• Evaluate equipment and processes for repeatability and make improvements as necessary.
• Investigates, recommends, and justifies new technologies, manufacturing methods and equipment to meet competitive business needs and improve efficiencies.
• Provide technical support to various departments in the Company.
• Develop and run protocols including IQ, OQ, and PQ activities as required.
• Create and revise documents such as Preventative Maintenance, Work Instructions, and Internal Specifications.
• Analyze process outputs using statistical methods to ensure stability.
• Interact with suppliers and obtain quotes as necessary.
• Perform cost analysis, provide budgets, and justify capital expenditures on projects.
• Analyzes and plans work force utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.

Who you are:

• Bachelor’s Degree in Engineering or equivalent experience required.
• 5-7 years of experience, preferably in a medical device or pharmaceutical industries.
• Experience in product/process transfers.
• Experience in biomedical textile processes is a plus.
• Proficient B2 English level is a must.
• Valid US Visa is a must.
• Demonstrated ability to lead and manage multiple projects with the ability to meet deadlines and within budget.
• Proficient computer skills using MS office, MS Project, and strong spreadsheet skills.
• Strong analytical, organizational, teambuilding and communication skills
• Independent self-starting work habits.
• Lean Manufacturing, Six Sigma, or associated Continuous Improvement methodology training
• Formal project management training.
• Experience with ISO 13485 and FDA guidelines.