R&D Engineer


The R&D Engineer’s primary functions include designing new products that ensure cost efficiency per Customer requirements and design inputs while conforming with regulatory standards and quality. The R&D Engineer will establish and maintain Design History Files, establish appropriate Design Verification and Validation methods, and perform and apply risk management techniques in a fast-paced environment. The R&D Engineer will be interfacing with Customers and Clients during the development process, and will exhibit a strong aptitude for communicating to Customers and Clients throughout the project.

The Engineer collaborates with Manufacturing Engineers, Quality Assurance, and Clients to design products and processes which are economically feasible to produce/implement and meets customer needs.

Essential Functions:

  • Engage with customers at the beginning of each project to fully understand customer requirements, timeline, and expectations. Proactively identify ambiguous or unidentified inputs as well as potential challenges at the front end of each project to ensure project efficiency and accuracy. 
  • Review, create, and maintain technical documents including: label templates, label control forms, 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. 
  • Manage all aspects of external suppliers that are relevant to a customer’s project including sterilization suppliers, bioburden testing suppliers, cleaning validation suppliers, and manufacturing suppliers. Relevant tasks include: obtaining quotes, shipping test parts, answering supplier questions, conducting design reviews (specific to manufacturing suppliers), and ensuring suppliers are adhering to timelines. 
  • Manage supplier assessment and qualification and the development of supplier quality agreements. Develop a strong working relationship with suppliers. 
  • Providing necessary training to MMD technicians prior to processing new products. 
  • Overseeing all aspects of production builds and verifying all documentation prior to release. 
  • Perform special projects and other duties as assigned. 

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.
  • Minimum 10 years relevant experience for Technical Client Manager; minimum 5 years relevant experience for Technical Client Specialist.
  • Preferred experience: Engineering/project management experience in the Medical Device field with history of success engaging with customers and suppliers 
  • 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. 
  • Detailoriented with excellent organizational skills. 

To inquire and/or apply for the R&D Engineering position, please send resume to Engineering Manager Michael.Seikel@MainstreamMedicalDevices.com

Mainstream stands as an equal opportunity employer and is committed to providing fair and equal treatment to its employees and applicants without regard to race, color, national origin, religion, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal state and/or local laws. Mainstream will make reasonable accommodations that are necessary to comply with disability discrimination laws.