Senior Engineer

Werfen•Bedford, MA

About The Position

The Senior Engineer will work in Laboratory Automation Systems Engineering, generating and managing testable system requirements, managing a risk database based on patient safety, and overseeing integration, verification, and validation activities in collaboration with a cross-functional team. The role contributes as an individual contributor, core team member, or technical lead for a specific project and is accountable for completing assigned deliverables according to approved schedules. The position independently plans and prioritizes moderately complex work, analyzes and interprets data, develops technical methods and processes, identifies and documents product defects, and communicates complex technical information. It also provides technical guidance and mentoring to others and supports or leads investigations related to product development or on-market activities.

Requirements

  • Bachelor's degree in Engineering, Science, or a related field.
  • Eight years of product development or relevant experience; four to six years for candidates with advanced degrees.
  • Experience working in Laboratory Automation for medical devices.
  • Experience running verification projects, including managing system requirements and product risk.
  • Experience working in a Linux-based operating system.
  • Proficiency in English.

Nice To Haves

  • In vitro medical device experience is highly desired.
  • Experience coding in one or more languages.
  • Experience with computer networking.

Responsibilities

  • Generate and manage testable system requirements.
  • Manage a patient-safety-based risk database.
  • Oversee integration, verification, and validation activities.
  • Contribute as an individual contributor, core team member, or technical lead for a project.
  • Complete assigned deliverables in accordance with approved schedules.
  • Author documentation and participate in design-control activities.
  • Independently plan, perform, and prioritize moderately complex tasks in alignment with corporate goals.
  • Analyze and interpret data, identify trends, and formulate next steps when required.
  • Lead, design, or develop new test methods, specifications, technical apparatus, software, and processes for moderately complex components and functions.
  • Identify product defects and outliers in results, and explain and document defects and their impact.
  • Communicate complex technical information to cross-functional teams through documentation, presentations, or technical summaries.
  • Provide technical guidance or supervision to group members and cross-functional technical teams, and mentor others.
  • Provide technical support for, or lead, investigations supporting development or on-market activities.
  • Independently generate predictable schedules for activities related to assigned projects.
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