Manufacturing Engineer II

General Responsibilities

• Mechanical engineering experience in a medical device environment which includes working with CAD, Solid Works, Pro E, etc. in conjunction with change control processes.
• Perform supplier sourcing, evaluation and management in conjunction with quality management systems in the design for manufacturability.
• Provide strong verbal and written skills in support for creation and development of standard operation procedures, work instructions, inspections documentation, change controls and visual aids as applicable.
• Create and maintain accurate documentation of tool drawings, design concepts and orders, in accordance with the Product Development and Quality Assurance functions.
• Collaborate with peers to design and develop supply chain manufacturing processes for new products, enhancements, product changes, and related fixtures and tooling that are consistent with zero defect level.
• Support Engineering Change Notice (ECN) and related Material Review Board (MRB) activities including disposition and root cause investigation of non-conforming materials.
• Participate through the project validation phases with transition to manufacturing operations which includes efficiency gains/improvements post pre-product status (includes tooling, fixtures, processes and costs).
• Participate in cross-functional teams with a focus on product packaging technologies, testing, validations and labeling (including IFUs – Instructions for Use) with Bar Coding and use of GTINs (Global Trade Identification Numbers).
• Assist in the evaluation of returned materials/products.
• Support and adhere to company policies, procedures, goals and objectives, QSR/FDA regulations and evaluate suppliers for good manufacturing practices.
• This position requires travel to supplier facilities to observe and evaluate supplier manufacturing and assembly processes.

Qualifications and Attributes

• Bachelor's Degree in Manufacturing Engineering or Mechanical Engineering.
• Minimum of 4 years' manufacturing engineering experience, with specific experience in medical devices/components.
• Strong knowledge of manufacturing technologies for Class I and II medical devices, specifically in the orthopedic and implantable space is highly preferred.
• NPI and product launch exposure experience.
• Experience drafting manufacturing change documents.
• Computer skills: Microsoft Excel, Microsoft Access, Microsoft Project, CAD, SolidWorks, Minitab, and ERP systems (QAD).
• Experience working in a dynamic medical device manufacturer and/or contract medical device manufacturer.
• Familiarity with statistical tools and concepts such as ANOVA and DOE methods.
• Knowledge of FDA and functional requirements for sterile, non-sterile, disposable and reusable devices.
• Excellent time management skills, take initiative to meet deadlines and the ability to prioritize workload and minimal supervision.
• A strong passion for product and process excellence and customer satisfaction.