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Project Engineer

2 months ago

Alpharetta, United States Acro Service Corp Full time

The Project Engineer - Healthcare (Contingent) is a member of the Surgical Solutions engineering team who supports projects and technical deliverables influencing design changes necessary to enable cost effective sourcing programs, and product lifecycle management activities including innovations to optimize manufacturability and/or product value. These efforts support cost efficiencies in the surgical solutions portfolio including surgical devices and equipment (class 1 and class II medical devices). You will collaborate closely with team members in Research & Development, Supply Chain, Quality, Regulatory, Finance, and Marketing to enable changes including the design, validation, and launch of these optimizations and innovations. The ideal candidate is experienced in the medical device product design and development process, change management process, test method development and validation, design verification and validation, and can navigate complexity and drive communication in a matrixed organization.


What You Will Do:

  • Identify, coordinate, and manage change implementation plans and execution of engineering change orders (ECO's).
  • Evaluate new opportunities for product design optimization through analysis of design impact, risk assessment, and benefits.
  • Support design and development activities through redlines of drawings, specifications, bills of materials and coordination of changes to technical documents.
  • Prototype product changes for proof-of-concept bench tests.
  • Develop and validate test methods to qualify/quantify design requirements.
  • Write and execute test protocols and reports including the ability to analyze data to define results and conclusions.
  • Estimate task timing, prioritize tasks, and maintain communication of status with relevant stakeholders including project manager(s) and supervisor.
  • Support large and/or highly complex projects.
  • Lead medium to low complexity projects.
  • Promote a mindset of continuous improvement.


Basic Qualifications:

  • Bachelor’s degree in a relevant technical engineering discipline (mechanical, biomedical, etc.) or similar technical discipline
  • 2+ years of experience in research and development engineering or process engineering supporting change implementation.
  • Proficient with MS Office including the ability to format and analyze data in MS Excel and format and write protocols and reports in MS Word.
  • Change Assessment and Management (ECO/ECN)
  • Specifications, Drawings, BOM change execution
  • Test Method Development, Validation, and Execution
  • Write Technical Protocols, Analyze Data, Write Technical Reports
  • Support bench tests and prototyping


Preferred Qualifications:

  • Experience working in a regulated field, preferably experience with medical devices, preferably experience with operating room disposables.
  • Experience working cross-functionally in a multi-site, matrix organization.
  • Strong communication skills including the use of MS Teams and SharePoint for collaboration, and the ability to present information efficiently and effectively including the use of MS PowerPoint.
  • Experience with statistical analysis tools and techniques including use of Minitab statistical software.
  • Experience with project management principles, project planning & timelines, and project budgeting.
  • Basic financial understanding of profitability analysis.
  • Medical Device background, ISO13485 & MedDev design controls
  • Basic understanding of cost and profitability analysis
  • Experience collaborating X-functionally in a Matrix environment
  • Project/task management fundamentals including forecasting
  • Communication skills including presenting technical evals/conclusions