Principal Engineer

Werfen•Bedford, MA

About The Position

Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Plans and conducts work requiring the application of extensive and diversified knowledge of engineering principles in broad areas of assignments and related fields. Generally, uses advanced techniques and the modification or extension of theories, concepts and practices in the specialty and/or related disciplines. Maintains a clear overview of a major product development. Makes sound judgments when compromises, necessitated by available time and technical capacity, must be made to meet set objectives. Mentors junior staff.

Requirements

Bachelor's degree in Engineering, Science or a related field
Twelve years of product development or relevant experience
Eight to ten years of product development or relevant experience for advanced degrees
Proficiency in English language required
Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical Thinking
Technically adept and confident
Leadership: Accountability, Decision Making, Influence, Communication
Mentoring

Nice To Haves

In vitro medical device experience highly desired

Responsibilities

Acts as an Individual contributor, core team or technical lead for a specific project or product line.
Accountable for the completion of assigned deliverables in accordance with approved schedules.
Authors documentation and participates in activities in support of design control.
Independently plans, performs & prioritizes tasks that are complex in nature, in alignment with corporate goals.
Analyzes and interprets data, identifying trends and formulating the next steps, while effectively performing trade off analysis, if required by the function.
Leads, designs and/or develops one or more of the following: new test methods, specifications, technical apparatus, software and processes for complex components and functions.
Evaluates complex designs or processes, with respect to acceptability, suitability and cost. Recommends preferred design options. Presents trade-off, if required by the function.
Identifies product defects and able to recognize outliers in results. Able to explain and document product defects and their impact.
Effectively communicates technical information to a multidisciplinary team in the form of documentation, presentations and technical summaries and promotes collaboration.
Technical expertise in more than one or a subject matter expert in at least 1 area.
Leads without authority & provides technical guidance to engineers and technicians assigned to him/her on a given project. Provides mentoring within or outside of their department.
Provides technical support for or leads CAPA or complaint investigations.
Independently generates predictable schedules for activities related to the function, understanding cross-functional dependencies.
May review and provide input to deliverables from other functions.
Recommends and drives improvement initiatives and motivates others to implement.
May be assigned CAPA ownership.