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Sage Product Development, Inc. · 5 days ago

Senior Product Development Engineer

Foxborough (Foxboro), MA

Full-time

Onsite

Senior Level

Sage Product Development, Inc. provides creative product development services to medical device companies. The Senior Product Development Engineer will manage product development projects, design and develop medical devices, and ensure that designs meet performance specifications and regulatory requirements.

Medical DeviceProduct DesignProject ManagementQuality Assurance

Responsibilities

Develop medical devices from concept through market introduction on a contract basis for client companies

Meet or exceed customer expectations

Manage product development projects

Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs

Proactively communicate task assignments to responsible individuals, and ensure that tasks are completed within the planned time

Track projects to project plans

Proactively report project status to Sage personnel and to the project’s client company

Generate project timing and expense estimates and prepare project proposals for client companies

Design and develop medical devices (disposable and reusable), catheters, equipment, implants, and/or packaging, from concept through market introduction

Ensure that designs meet performance specifications, regulatory and manufacturing requirements

Interact with client companies in a professional manner

Proactively communicate with client companies to ensure an ongoing two-way exchange of information

Generate innovative concepts for new medical device designs to satisfy customer and clinical requirements

Lead and participate in concept generation activities, including brainstorming sessions

Refine, rate, rank and/or otherwise assess concepts

Utilize SolidWorks to develop detailed 3-D CAD models and drawings, including component, subassembly, and top-level drawings

Investigate and evaluate existing technology for application to projects

Design and implement new methodologies, materials, machines, processes or products as required to achieve product development goals

Produce prototype devices for testing and evaluation

Work with internal and/or external resources to produce prototype device components

Assemble and/or evaluate prototype devices

Conduct bench and/or animal feasibility studies

Conduct product verification and validation testing to demonstrate product safety and efficacy

Determine what testing is required to satisfy product requirements, to investigate potential failure modes, and to otherwise address the project design inputs

Develop protocols, plan testing, and perform or monitor testing

Utilize statistical methods as required to plan testing and to analyze test results

Write test reports which draw conclusions from the results

Conduct risk analyses

Conduct and document Failure Mode and Effects Analyses

Perform tolerance analysis of components and assemblies to ensure proper fit and functionality

Coordinate activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet customer expectations

Maintain detailed essential product and process documentation throughout all phases of research and development

Maintain Design History Files (DHFs)

Ensure that DHFs are accurate, complete and well organized

Prepare documentation release packages, including detail drawings, bills of material, and/or procedures

Approve Document Change Orders (DCOs) and obtain approvals from others as required

Ensure that all work satisfies the requirements of client companies’ Quality Systems, with particular emphasis on Design Control

Conduct and document Design Reviews

Participate in Material Review Board activities

Make decisions regarding product and material discrepancies and initiate appropriate action to prevent subsequent problems or discrepancies

Date, sign and have witnessed all documents that may establish inventorship dates

Some local travel (i.e. by car)

Occasional long-distance travel (i.e. by plane)

Any other duties as assigned

Qualification

SolidWorks 3D CADMedical device designProject managementFDA QSR knowledgeProbabilityStatisticsFinite element analysisResource managementCommunication skillsCustomer focus