Lead Manufacturing Test Engineer

Technology Boston, Massachusetts


Description

Who We Are:

EPAM Continuum integrates business, design, and technology consulting to focus on accelerating breakthrough ideas into meaningful impact. Driving transformation in today’s world requires a uniquely constructed network of connected teams, working across silos, to help tackle our client’s biggest challenges. This is core to our DNA.

The EPAM Continuum network of teams is made up of multi-disciplinary professionals with diverse experiences, including design & business strategists, architects, product, service, & interaction designers, technologists, data analysts, prototypers, and electrical, mechanical, & software engineers.

Some of the world’s most well-respected brands and organizations rely on EPAM Continuum as their innovation partner, including American Express, Bose, Fisher-Price, Herman Miller, Johnson & Johnson, Nestle, PepsiCo, Procter & Gamble, Reebok, Samsung, Southwest Airlines, and UnitedHealthcare.

We want to meet great people who are interested in working in a global firm where culture matters and curiosity is valued. We work collaboratively. We think globally. We’re passionate. We firmly believe that we can advance lives and bring businesses into the future.  And we make it happen every day.

Who You Are:

We are looking for a Lead Manufacturing Test Engineer to join our team. The lead manufacturing test engineer would be responsible for providing technical expertise in testing and product knowledge, writing test procedures and developing test plans, configuring necessary hardware and operating environments as needed to complete and execute assigned testing. In addition, the Lead Manufacturing Test Engineer will provide technical know-how on products, sensing, operating systems and specialized environments.

The ideal candidate would have a background in product design and engineering and proven technical writing skills, effective communication skills, analytical skills, organizational skills, and interpersonal skills. They must also be self-motivated, reliable to deliver on time, a quick-thinker, and be able to work in a fast-paced work environment.

Responsibilities:

  • Partner with R&D to set requirements for Product Test systems.
  • Take the lead to specify, design and develop test systems and test protocols for a Medical Device or Life Science production system.
  • Work with internal and external partners to develop, install and validate test systems and manufacturing systems.
  • Participate on interdisciplinary teams to identify scope for required manufacturing test systems
  • Manage the project scope, schedule and budgets for the development, breadboarding and verification of new test systems.
  • Support Test System Design & Validation with thorough documentation of User Requirements Specifications, Functional design specifications, IQ, OQ, FAT, SAT and PQ efforts.
  • Determine test system requirements in accordance with FDA Regulations using: System Hazard Analysis, DFMEA and PFMEA.

 

Requirements:

Detail-oriented, energetic self-starter with strong communication and organizational skills. The successful candidate will have a proven ability to multi-task and work collaboratively as well as independently in a dynamic environment. The position requires a minimum of 10 years of experience in test engineering, preference for experience in Medical Device/Life Science organization. Additional qualifications are as follows:

 

  • S. in related Engineering discipline, M.S. a plus
  • 10+ years applicable experience in Test Development, Systems Engineering or Manufacturing.
  • Working understanding of the principles of Medical Device and healthcare regulations including FDA’s Quality System Regulation (QSR) and European regulations.
  • Excellent organizational and time management skills.
  • Detail oriented, dependable and willing to handle multiple priorities.
  • Successful communication skills and decision-making ability.
  • Familiar with (PDM) and Document Control systems
  • Experience in software validation a plus.
  • Travel up to 25% may be needed