Job description

POSITION SUMMARY The R&D Project Engineer is the technical lead for evaluating proposed design changes to released medication delivery and vascular care products within the MDVC Sustaining Engineering program. This engineer takes cost improvement ideas through feasibility and appraisal, generating the technical evidence, risk assessment, and business case that leadership needs to decide whether a project moves forward into execution. The MDVC platform depends on a steady flow of well-vetted design changes, including material, component, packaging, and supplier changes, to offset cost pressure while protecting quality on high-volume products such as syringes, needles, and flush. This role directly determines how quickly and how reliably those ideas become approved, executable projects. KEY RESPONSIBILITIES Feasibility and Technical Appraisal *Own the technical assessment of proposed cost improvement design changes to released products, from idea intake through completion of feasibility and appraisal. *Define the critical assumptions for each project (what must be true for the change to work) and design the shortest credible path of analysis and testing to confirm or reject them. *Evaluate proposed material, component, packaging, and supplier changes, such as alternate resins, lubricants, elastomers, and outsourced components, against product specifications, functional performance requirements, and applicable standards. *Plan and execute feasibility testing, including sample and prototype builds, bench testing, and comparative performance testing against the current design. *Develop, troubleshoot, and execute test methods; specify fixtures and measurement equipment; perform measurement systems analysis; and analyze results using sound statistical methods. Design Change and Risk Assessment *Assess the impact of each proposed change on design outputs, including drawings, specifications, bills of material, labeling, and Design History File content. *Partner with Quality Affairs and Operations in risk assessments (for example, dFMEA, pFMEA and risk management file updates in accordance with ISO 14971) to identify risks introduced by the change and the controls required. *Define a preliminary verification and validation strategy and estimate the scope, cost, and duration of execution-phase testing, including design verification, biocompatibility, sterilization, packaging, and shelf-life considerations as applicable. *Partner with Regulatory Affairs to identify regulatory implications, including whether a change may require notification or submission in key markets. Business Case and Decision Support *Build and validate project business cases with Finance, Procurement, and site partners, including savings basis, one-time project costs, capital needs, and timing of savings. *Document appraisal results using the MDVC Project Feasibility Appraisal Review process and present clear go / no-go recommendations at technical reviews and platform prioritization forums. *Write concise, technically rigorous reports that state what is known, what is assumed, and what risk remains, so leadership can make informed decisions effeciently. *Recommend stopping projects early when the technical or financial case does not hold, before significant time and spend are committed. Cross-Functional Leadership and Handoff to Execution *Coordinate input from Quality, Regulatory Affairs, Medical Affairs, Procurement, Supplier Quality, Sterilization, Packaging Engineering, and site engineering without direct authority. *Engage suppliers to obtain samples, technical data, and change information needed for evaluation. *Deliver an execution-ready project package (scope, risk assessment, test strategy, resource estimate, and schedule) so approved projects transfer cleanly to the execution team. *Maintain accurate project status, risks, and next steps in platform tracking tools to support pipeline visibility and portfolio decisions. *Comply with quality policies, design control procedures, and all applicable local, state, federal, and safety requirements. REQUIRED QUALIFICATIONS *Bachelor’s degree in Mechanical, Biomedical, Plastics, Chemical, or Materials Engineering, or a closely related engineering discipline. *Minimum of 3 years of engineering experience in medical device product development, sustaining engineering, or design change engineering in an FDA-regulated environment. *Working knowledge of design controls (FDA 21 CFR 820 and ISO 13485) and risk management (ISO 14971), including how design changes are assessed, documented, and verified. *Hands-on experience writing and executing test protocols, developing test methods, and analyzing data with statistical tools such as Minitab or JMP. *Strong engineering fundamentals for plastic and elastomeric components, assemblies, and packaging. *Demonstrated ability to write clear, technically rigorous protocols and reports. *Ability to manage several projects in parallel, lead through influence, and make sound recommendations with incomplete information. *Clear, concise written and verbal communication, including presenting to both technical and leadership audiences. PREFERRED QUALIFICATIONS *Experience with high-volume, single-use medical devices such as syringes, needles, catheters, or prefilled flush products. *Experience evaluating material or supplier changes, including resin, elastomer, lubricant, or packaging material alternatives. *Familiarity with standards relevant to medication delivery devices, such as ISO 7886, ISO 80369, and ISO 11607. *Experience building or supporting cost improvement business cases. *Working knowledge of injection molding, insert molding and automated assembly sufficient to judge the manufacturability of a proposed change. *Design of experiments (DOE) experience; Six Sigma Green Belt or Design for Six Sigma training. *Experience with PLM, ERP, and document control systems such as SAP, Windchill, or Agile. *Prior experience with Medication Delivery Solutions products or processes. Pay Range: 38-42/hr *based on experience

Requirements

Must-haves

Feasibility and Technical Appraisal
Own the technical assessment of proposed cost improvement design changes to released products, from idea intake through completion of feasibility and appraisal.
Define the critical assumptions for each project (what must be true for the change to work) and design the shortest credible path of analysis and testing to confirm or reject them.
Plan and execute feasibility testing, including sample and prototype builds, bench testing, and comparative performance testing against the current design.
Develop, troubleshoot, and execute test methods; specify fixtures and measurement equipment; perform measurement systems analysis; and analyze results using sound statistical methods.
Design Change and Risk Assessment
Assess the impact of each proposed change on design outputs, including drawings, specifications, bills of material, labeling, and Design History File content.
Partner with Regulatory Affairs to identify regulatory implications, including whether a change may require notification or submission in key markets.
Business Case and Decision Support
Build and validate project business cases with Finance, Procurement, and site partners, including savings basis, one-time project costs, capital needs, and timing of savings.
Document appraisal results using the MDVC Project Feasibility Appraisal Review process and present clear go / no-go recommendations at technical reviews and platform prioritization forums.
Write concise, technically rigorous reports that state what is known, what is assumed, and what risk remains, so leadership can make informed decisions effeciently.
Recommend stopping projects early when the technical or financial case does not hold, before significant time and spend are committed.
Cross-Functional Leadership and Handoff to Execution
Coordinate input from Quality, Regulatory Affairs, Medical Affairs, Procurement, Supplier Quality, Sterilization, Packaging Engineering, and site engineering without direct authority.
Engage suppliers to obtain samples, technical data, and change information needed for evaluation.

Nice-to-haves

Experience with high-volume, single-use medical devices such as syringes, needles, catheters, or prefilled flush products.
Experience evaluating material or supplier changes, including resin, elastomer, lubricant, or packaging material alternatives.
Familiarity with standards relevant to medication delivery devices, such as ISO 7886, ISO 80369, and ISO 11607.
Experience building or supporting cost improvement business cases.
Working knowledge of injection molding, insert molding and automated assembly sufficient to judge the manufacturability of a proposed change.
Design of experiments (DOE) experience; Six Sigma Green Belt or Design for Six Sigma training.
Experience with PLM, ERP, and document control systems such as SAP, Windchill, or Agile.
Prior experience with Medication Delivery Solutions products or processes.

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