Senior Engineering Group Leader - Process Engineering

Werfen; Pennsylvania; On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a seasoned engineer to lead product development initiatives. This role involves overseeing the application of technology across various programs, ensuring compliance with safety standards, and managing a team of engineers. The ideal candidate will have extensive experience in product development, particularly in the medical device sector, and a strong background in design for manufacturability. Join a collaborative environment where your leadership and technical skills will drive innovation and success in the product lifecycle.

Qualifications

• 15 years of product development experience required.
• Experience with IVD medical devices preferred.
• Strong mentoring and coaching skills.

Responsibilities

• Oversee technology application and ensure compliance with safety standards.
• Manage engineering analysis and documentation for product development.
• Coordinate cross-functional teams and manage project scopes.

Skills

Product Development

Design For Manufacturability (DFM)

Statistical Analysis

Six Sigma Methodologies

Cross-Functional Communication

People Management

Education

Bachelor's in Mechanical Engineering

Master's in Engineering

Tools

Test Automation Equipment

Job description

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
• 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

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

Travel requirements:

• <5% of time