Senior Engineering Group Leader - Process Engineering

Werfen•Bedford, MA

6h•Onsite

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain, and is a worldwide leader in specialized diagnostics in areas like Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. They also have an Original Equipment Manufacturing (OEM) business line for customized assays and biomaterials. Werfen operates directly in 30 countries and through distributors in over 100 territories, with Headquarters and Technology Centers in the US and Europe, and a workforce of more than 7,000. Their success stems from a focus on rapidly evolving diagnostic areas, commitment to customers, and dedication to innovation and quality, aiming to provide healthcare professionals with valuable solutions to improve hospital efficiency and patient care. The Position Summary states that the Senior Engineering Group Leader - Process Engineering reports to the Functional Manager and is responsible for assigning and overseeing the practical use of technology across multiple programs, ensuring the proper use of common architecture. This role involves receiving requirements from Project/Program Managers and preparing specifications to design, develop, or integrate technologies for products and their derivatives. The leader is responsible for all Functional Specifications and Theory of Operation documents, including schematics, design layouts, detail and assembly drawings, bill of materials, associated analytical data, and implementation documents. The individual may act as a group leader or lead engineer on a major program, perform independent development, and manage several smaller projects.

Requirements

Bachelor’s degree in ME/EE/System Engineering (or equivalent) with a minimum of 15 years of product development experience, or a BS and MS in Engineering discipline with at least 10 years of experience
Collaborate with Product Design & Analytical Groups
Ensure designs incorporate DFM (Design For Manufacturability) techniques
Risk Assessment
Create and maintain pFMECA’s & Process Impact Analysis (PIA)
Contribute to the dFMECA as required (for new product introduction) and supplement determination of critical to quality (CTQ) components.
Develop control plans and inspection routings.
Develop or Select Test Automation & Equipment
Lead proof of concept demonstration of robust and novel test & automation solutions, and identify/develop equipment required for product manufacture
Process Development
Develop new manufacturing processes employing Six Sigma methodologies to ensure processes meet capacity and capability requirements.
QA assurance methods result in reduce error and decreased Time-to-Market
Create documentation framework for new materials, assemblies, and processes
Develop floors plans, facility requirements, setup preliminary operations area or pilot lab test area.
Process Validation
Validate new processes implementing statistical analysis (IQ, OQ, PQ, GR&R, SW, Val, FAI?)
Transfer
Transition validated process to operations: provide training, doc packages, on-floor support
Proven ability to mentor and coach junior engineers, particularly in DfX (Design for Excellence) principles such as reliability, cost efficiency, manufacturability, and ease of assembly
Familiarity with quality systems and regulations applicable to medical devices
Exceptional cross-functional communication and collaboration skills
Strong people management skills including driving a design team towards success as well as career development
Demonstrated ability to manage and motivate a design team
A clear, systems-level understanding of product development lifecycle
Effectively planning and organizing tasks with ability to drive direct reports for achieving objectives
Requires a B.S. in Engineering and at least 15 years of experience or an M.S. Degree and at least 10 years of experience in degreed field.
Must have a demonstrated interest in managing a product development effort.

Nice To Haves

New product development experience specific to IVD medical devices
Ability to use networking skills to connect direct reports with technical leaders and subject matter experts to improve technical acumen
Ability to influence and align cross-functional teams around shared goals and foster transparent communication
Comfortable leading through all phases of the product development lifecycle—from product definition, conceptualization, design, implementation, verification and validation, and design transfer
Project management experience including risk assessment, budget oversight, and executive-level reporting

Responsibilities

Oversees the shared application of technology across programs in area of expertise.
Performs design reviews to ensure that designs are reliable and meet cost targets, product requirements and all safety standards; Presents findings and implements solutions.
Performs all required engineering analysis of characteristics of the system being designed.
Ensures the proper access and availability of required development tools.
Oversees the proper implementation of required documentation and archiving as defined by corporate compliance agreements.
Manages and supervises team consisting of engineers and technicians as required.
Produces realistic schedules that are consistent with phased delivery requirements of the PLC.
Ensures availability of relevant resources to programs and anticipate future needs.
Coordinates and integrates development efforts with other technical groups.
Responds to changes in the scope of projects and impact on delivery time/functionality.
Identifies capital equipment requirements for immediate and budgetary considerations.
Responsible for yearly review of section personnel and recommends proper training.
ECO control.
Reviews manufacturability, reliability and serviceability analysis and offers cost reduction design and recommendation.
Assures designs meet reliability engineering requirements.
Call rate reduction participation