GIE PPD Engineer 3

Role Overview

• Provide a leading Product & Process Design role in planning and execution of medical device projects for the Medication Delivery Solutions (MDS) Business Unit.
• Provide product design feedback and be the assembly subject matter expert (SME) for cross functional teams as applicable.
• Specify process technology, maintain timelines, associated project budgets and actively de-risk all aspects for product and process development.
• Provide updates to supporting management, cross-function teams(s) and BU Operational leadership.
• Define manufacturing technology strategy for new products, support product design by manufacturability analysis of the devices and their packaging and ensure a successful transfer to the production floor.
• Lead engineering efforts to build pilot lines of new manufacturing processes to attain process capability and OEE.
• Responsible for working with R&D across MDS on the design and development of current and new products.
• Perform DFMA (Design For Manufacturing & Assembly) and DFSS (Design For Six Sigma) analysis and establish assembly requirements and implement process controls to ensure product quality and consistency.
• Provide expertise in design for manufacturability & assembly principles.
• Ensure the assembly process is understood well to minimize risk.
• Develop and execute assembly risk mitigation plans.
• Collaborate cross-functionally, especially with R&D and manufacturing specialists to ensure design aligns with product requirements, and product designs are optimized for manufacturability, assembly, and overall performance.

Requirements

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or equivalent required.
• Four (4) years’ experience or MS degree with two (2) years’ experience preferred.
• Experience in mechanical design, with focus on applying DFMA principles.
• Industrial experience in process development is preferred.
• Ideally experienced in medical device production.
• Experience in process validation, writing protocols and reports to support verification and validation activities for product commercialization; ability to complete validation.
• Intermediate knowledge of design and simulation software’s such as the following: SolidWorks, AutoCAD, ProModel, FlexSim.
• Ability to build and implement project plans.
• Basic tooling, design and drafting knowledge.
• Ability to analyze data, interpret results, and write reports.
• Proficient in statistical software.
• Experience with both manual and semi-automated production lines preferred.
• Excellent oral and written communication skills.
• Excellent technical skills including project management, organization, planning, and capital budgets.
• Excellent Interpersonal Skills
• able to express ideas and collaborate effectively with multidisciplinary teams.
• Ability to work with minimal guidance, conceptualize ideas, motivate, and focus individuals and teams and drive projects through completion on time and on budget.
• Understanding and ability to implement DOEs, process characterizations and validations using standard statistical techniques.
• Understanding of GMPs and medical device regulations as they apply to manufacturing.
• Ability to interpret, edit and correct part drawings
• Understanding of GD&T
• Understanding of project management and budgeting.

Tech Stack

• Assembly

Benefits

• Health insurance
• 401(k) matching
• Flexible working hours
• Paid time off
• Professional development opportunities