Manufacturing Engineer

A: Purpose and Scope
The Engineer is to work within a regulated quality system environment to oversee and improve manufacturing processes to produce medical devices. The manufacturing engineer’s responsibilities include identifying areas for improvement, maintaining high levels of manufacturing and product quality, implementation of new product and processes, as well as ensuring cost-efficiency and conformance with regulatory standards. The Engineer will work with new and existing suppliers to identify specifications and processes. The Engineer will write, execute, and report engineering verification and validation protocols in support of the implementation of manufacturing processes.
(Full time, 5+ years’ experience, strong in mechanical fixture design and implementation of production processes)

B: Responsibilities
• Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
• Design and implement fixtures and other manufacturing processing aids.
• Provide engineering support and training to the manufacturing line.
• Create and perform engineering validations and verifications on new and existing product or equipment.
• Work with suppliers on the development of specifications and validation/qualification of processes.
• Support R&D/Operations in the improvement and/or development of manufacturing for scaling of production.
• Support Regulatory and Operations in the sourcing, qualification, and implementation of new potential suppliers.
• Work with Quality and suppliers to address nonconformances, CAPAs and SCARs.
• Support prototype and pilot production of new products, cost savings efforts, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
• Prepares engineering change orders (ECO) and coordinates the deployment of changes including training operation team members.
• Develop KPIs and report manufacturing performance metrics.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
• Other duties as assigned

C: Organizational Relationships
This position reports to the Director of Operations

JOB REQUIREMENTS

A: Skills & Abilities
• Excellent problem solving, strategic thinking, decision making, analytical, and oral / written communication skills required.
• Results oriented, strong sense of ownership, and committed to achieving meaningful results.
• Ability to work well under pressure to meet deadlines in a cross-functional team environment.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions.
• Ability to work independently with minimal supervision on a daily basis.
• Has knowledge of commonly used concepts, practices and procedures within the Medical Device or related industry.
• Experience and knowledge of GMP practices and ISO 13485 regulatory requirement

B: Education and Training
• Bachelor’s Degree in Engineering or related field required.
• Minimum 5+ years of experience in medical device industry
• Advanced knowledge of MS Office Suite required.
• Advanced knowledge of CAD software required – SolidWorks preferred.
• Knowledge of descriptive statistics at minimum required.
• Understanding of high-volume production processes (e.g., injection molding, machining, additive manufacturing) preferred.
• Experience in supplier interaction.
• Experience in manufacturing processes and new product implementation.