GIE PPD Engineer 3
BD
full-time
Posted on:
Location Type: Office
Location: Sandy • Utah • United States
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Tech Stack
About the role
- 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.
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
mechanical designDFMADFSSprocess developmentprocess validationdata analysisstatistical softwareproject managementdesign for manufacturabilitytooling design
Soft Skills
communication skillsinterpersonal skillsorganizationplanningcollaborationmotivationfocusrisk mitigationproblem-solvingleadership