Sr. Manufacturing Engineer

Summary: 

Monday-Friday, direct hire opportunity to join the manufacturing team at a specialty pharmaceutical company! In this position, you will play a lead role in supporting the manufacturing requirements of commercially released products as well as products that are in various stages of development. This includes:

• Leading Simple to complex manufacturing projects by applying manufacturing engineering principles to achieve manufactural products and statistically capable processes.
• Converting devices designs into process/equipment requirements, then into tooling/equipment concepts and prototypes, and finally, into commercial production.
• Working with external suppliers to deliver processes and/or equipment that meets the product/project requirements.
• Considering regulatory requirements for device/drug combination products with the end goal of delivering final commercially released processes that can meet a high Overall Equipment Effectiveness (OEE) and quality requirements.

Responsibilities:

• Develop manufacturing processes that are capable of achieving design requirements from laboratory through pilot line, into full scale manufacturing.
• Create and/or execute, as well as formally document, manufacturing process equipment validations consistent with company requirements and standard operation procedures.
• Coordinating efforts to design, develop, and validate manufacturing processes using tools such as Design Of Experiments (DOE), Measurement System Analysis (MSA), Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), and capability analysis.
• Develop and/or communicate process/equipment specifications for process/equipment suppliers regarding quotes based on the product and customer requirements.
• Engaging and/or leading cross functional teams in Design for Manufacturability (DFM).
• Create detailed project plans and manage the execution of assigned projects.
• Develop effective relationships (internally and with suppliers).
• Communicate and manage through adversity-both internally within the company and with suppliers.
• Work closely with a broad and diverse range of customers including pharmaceutical companies and process equipment suppliers to ensure that the company’s manufacturing process/equipment requirements are met, as well to ensure a deep and current understanding of the customers/markets served by the company.
• Bring forward and deploy best practices in manufacturing engineering excellence.
• Ensure integrate approach/process with device design, process/equipment suppliers, and other strategic partners in the business.
• Deliver results: support commercial manufacturing, support assigned product development projects from a manufacturing perspective, and take a lead role in striving to achieve manufactural products that have high quality, and robust manufacturing processes in collaboration with Product Development/Quality/Suppliers.

Qualifications:

• Bachelor’s degree in Engineering or technology related field required.
• Master’s degree in Engineering or Business preferred.
• Six sigma black belt preferred.
• 7-10 years of experience in medical devices.
• 7-10 years of experience in manufacturing process development including characterization, process optimization, validation, and ramping production for high-volume specifications in the medical device industry.
• Proven ability to write through technical protocols, plans, and reports.
• Ability to provide innovative solutions to complex problems.
• Excellent written and verbal communication skills.
• Experience creating and writing process/equipment IQ/OQ/PQ validations, including test method validations.
• Experience executing process/equipment IQ/OQ/PQ validations, and documenting such in written final technical reports.
• Experience working with a variety of assembly, plastic injection molding, and machining suppliers.
• Experience with equipment and tooling designs including machine specifications.
• Experience supporting/representing the manufacturability/manufacturing processes for commercially approved products; as well as products that are in various stages of product development but planned for future commercial release.
• Ability to communicate vertically and horizontally through multiple channels, as well as vertically and horizontally with suppliers.
• Knowledge related to regulatory requirements for GMP.
• Experience managing and leading key manufacturing and/or engineering projects.
• Innovation and creativity desirable.
• A solid track record of completing successful manufacturing projects, on time and within budget is essential.
• Steeped in engineering and device process/product commercialization process improvement.

Suna provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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