Senior Engineering Group Leader - Process Engineering

Werfenlife SA.; Bedford (TX); On-site; USD 90,000 - 150,000; Full time

Job summary

An innovative company is seeking a Senior Engineering Group Leader to oversee technology application and product development in a dynamic environment. This role involves managing engineering teams, ensuring compliance with safety standards, and driving design reviews to meet product requirements. With a focus on collaboration and mentorship, the position offers a unique opportunity to influence the development of cutting-edge medical devices. If you are passionate about improving healthcare through technology and thrive in a fast-paced setting, this is the perfect role for you.

Qualifications

• 15+ years of experience in product development or 10+ years with an MS.
• Strong understanding of product development lifecycle and DfX principles.

Responsibilities

• Oversee technology application across multiple programs and ensure compliance.
• Manage and mentor a team of engineers and technicians.

Skills

Product Development

Design for Manufacturability (DFM)

Six Sigma Methodologies

Statistical Analysis

Cross-functional Communication

People Management

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Test Automation Equipment

Quality Systems

Job description

Senior Engineering Group Leader - Process Engineering

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

1st

About the Position

Introduction

Werfen

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.

Overview

Position Summary:

Reporting to the Functional Manager, responsible for assigning and overseeing the practical use of technology across multiple programs assuring the proper use of common architecture. Receives requirements specifications from the ProjecUProgram Managers and prepares specifications to design, develop or integrate technologies required to make a product and its specific derivatives. 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 any implementation documents. May act as group leader or lead engineer on a major program, perform independent development, and be responsible for a number of smaller projects.

Responsibilities

Key Accountabilities

Essential Functions:

• 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

Required Qualifications:

• 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
• 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

Preferred Qualifications:

• 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

Qualifications

Minimum Knowledge & Experience Required for the Position:

• 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.

International Mobility: Required:

• No
• <5% of time

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.