Manufacturing Engineer I/II- Medical Devices

Location – Pittsburgh, PA

Our Global Medical Device client is expanding and has created 3 new Manufacturing Engineering I/II positions that would be responsible for developing and implementing changes to medical device product design and/or manufacturing process to achieve significant quality, cost, and reliability improvements. The candidate(s) would be participating in cross functional teams activities, working with other business units to identify and fix manufacturability and testing issues. Works cross-functionally with R&D, Quality and Regulatory to ensure that the manufactured medical devices meet defined requirements.

Principal Responsibilities:

  • Act as team member for large scale, complex, manufacturing projects to ensure successful manufacturing of medical devices through cross-functional collaboration with other business units, coordination of overall project and budget management.

  • Ensure that production processes and systems as well as product designs for both existing and new products produce the highest possible quality and lowest possible cost.

  • Responsible for driving and implementing multiple improvement programs and following-up on the results achieved, including: Quality Monitoring and Actions, Production Efficiency, Improve Assembly Methods, Document and Implement Approved Changes.

  • Communicate proactively, openly, and cooperatively within the department and with management team to keep team informed; provides oral reports, and prepares timely and clearly written status reports, updates, and technical presentations.  May be the project leader on Lean/Six Sigma initiatives and Cost Improvement Projects, 5S, Kaizen events.

  • Proactively identifies, communicates, and refers problems or coordination needs to leadership; provides timely detailed background/data to support problem-resolution; seeks guidance as necessary to respond to needs or changes, and quickly assesses requirements to meet target milestones, goals, and deadlines. Takes initiative to offer suggestions for improved methods, processes, products, services, or techniques.

  • Translates engineering requirements, and design specifications into the manufacturing space. Interfaces with customers, suppliers, application users, and other technical and support personnel to support efforts.

  • Provide technical leadership, trains, and mentors less senior employees to support business initiatives and strategic goals, and evaluates or troubleshoots problems. Transfers knowledge/ technology solutions within or across groups.

  • Proposes technical solutions to resolve issues, and evaluates short and long term impact of recommendations made independently, or proposed.

  • Learns and applies standards, processes, policies, practices, techniques, and tools throughout the product/system development lifecycle including Standard Operating Procedures (SOP’s) and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems.

  • Solves routine/basic/complex problems using specialized engineering principles, tools, and methods to recognize and formulate problems, collect data through observation and experiment, and forms, tests, and validates hypotheses; efficiently selects and uses laboratory equipment and tools, and clearly documents, communicates, and summarizes technical findings and results for status updates, coordination, and recommendations.

  • May guide the work of others; communicating clearly both orally, and with written technical specifications.

Candidate Education:

  • Required Bachelor’s Degree Engineering

  • Preferred Bachelor’s Degree Chemical or Biomedical Engineering

Candidates Experience:

  • Required 2-5 years related experience in a manufacturing environment

  • Required medical device manufacturing experience

  • Preferred lab experience working with blood

  • Preferred experience with medical device development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems

Candidate Skills:

  • Chemical Engineering

  • Biomedical Engineering

  • Medical Device Manufacturing

  • Data Analysis

  • Experimental Design

  • Microfluidics Manufacturing, Design and Application Experience

  • Reagent Mixing and Scaling for Manufacturing

  • Root Cause Analysis

  • Problem Solving

If interested, please send resume to ecallender@daleyaa.com.

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