Sage Product Development, Inc. · 5 hours ago
Product Development Engineer
Foxborough (Foxboro), MA
Full-time
Onsite
Mid LevelSage Product Development, Inc. provides innovative product development services to medical device companies, seeking a Product Development Engineer. The role involves designing and developing medical devices from concept through market introduction, ensuring compliance with performance specifications and regulatory requirements while maintaining communication with client companies.
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
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
Significant local travel (i.e. by car). Occasional long-distance travel (i.e. by plane)
Any other duties as assigned
Qualification
Required
Bachelor's degree in Mechanical or Bio-Engineering is required
Some prior medical device product design and development experience is required
Demonstrated ability to bring products from concept to market
Ability to interact with client companies in a professional manner
SolidWorks 3D CAD proficiency is required
Knowledge of probability and statistics
Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit
Preferred
Master's degree in engineering, management or business is a plus
Company
Sage Product Development, Inc.
Sage Product Development, Inc. provides fast, efficient and creative product development services to medical device companies.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Jeffrey Cerier
President, co-founder
Recent News
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