Full-Time

Essential Functions:

• Evaluate and assess material selection, strength requirements, and manufacturing processes 
• Conduct risk assessments, and author verification & validation documents 
• Creation and maintenance of requirements for new products and ensuring that the DHF is compiled/completed in accordance with MMD SOP’s    
• Incorporate FDA, ASTM and ISO standards through the product life cycle, designing and developing the required inspection and process control methodologies   
• Review, create, and maintain technical documents including: design and development documentation, risk management files, custom work orders, work instructions, test protocols, test reports, and standard operating procedures 
• Release technical documents into the MMD Quality System via the DCO process 
• Awareness of MMD Quality Management System (QMS), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) 
• Perform investigations/evaluations for issues affecting product quality post‐launch 
• Perform special projects and other duties as assigned 
• Analytical Skills – need to be able to identify areas of low efficiency and work to provide improvements 
• Lean Manufacturing Skills – must be able to identify and eliminate waste within the system 
• QA and QC Skills – such as ISO 9000, Six Sigma, Lean Six Sigma, Statistical Process Control, etc 
• Communication Skills – will work with manufacturing employees at all levels and need to be able to effectively explain the relevant points of equipment to each. Also needed for successful project management 
• Technical Skills – must be able to work with different technology to provide a solution that produces the required result in the most efficient way possible 
• Commercial Awareness – must keep the “bigger picture” in mind at all times when considering each step of the manufacturing process 
• Problem Solving Skills – have to take a concept of a process and establish the equipment needed to make it happen 
• Organizational Abilities – should be able to prioritize tasks, set schedules and work between different projects to achieve overall business goals 

Position Requirements:

• A bachelor’s degree in life sciences or engineering (or a related field) and/or a combination of practical and educational experience in the medical device industry is required.  
  • Junior Engineer: 0-3 years in manufacturing environment or interface with supplier operation. Typically assigned supportive tasks. 
  • Engineer: 3-7 years in manufacturing environment or interface with supplier operation. Typically assigned project(s) with moderate impact to the organization. 
  • Senior Engineer: Level 7+ years in manufacturing environment or interface with supplier operation. Typically assigned a large project with significant impact to the organization and is an SME. 
  • Senior Engineer: 10+ years in manufacturing environment or interface with supplier operation. Responsible for large projects with significant impact to the organization, may have supervisory or mentoring role, and is an SME.
• Demonstrated experience working within FDA-regulated quality systems and strong knowledge of QSR requirements 
• Thorough understanding of technical engineering drawings, common dimensioning/tolerancing, design for manufacturability assessments, common manufacturing processes, medical device materials, and surface finish/surface treatments 
• Ability to review, interpret, and write technical reports and associated documentation 
• Proficiency with Microsoft Office 
• Well-developed written, oral, interpersonal, and negotiation skills 
• Detail-oriented with excellent organizational skills