Principal Process Engineer

Werfen•Bedford, MA

1d•$150,000 - $165,000

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Position Summary: 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

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.
Experience leading the development of test strategies, execution process validation, including but not limited to: IQ, OQ, PQ, Guage R&R, DoE, process capability.
Must have experience in design requirements and risk management (pFMEA), driving risk mitigation to closure in collaboration with cross-functional teams.
Experience working with electromechanical assemblies and instrumentation and test fixtures.
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.
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.
Partner with Quality Engineering and Regulatory teams to support phase planning readiness and contribute to the Design History File (DHF)
Independently generates predictable schedules for activities related to the function, understanding cross-functional dependencies.
Responsible for estimating and planning validation activities across the development lifecycle
Transition validated process to operations: provide training, procedures, and on-floor support
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.