Sustaining/Product Life Cycle Electrical Engineer

Sustaining/ Product Life Cycle Electrical Engineer - Mid-level  ( Medical Device )

Exciting new technology  in medical device that quickly and painlessly improves lives 
Greater Boston area 
 

Summary: 

As a member of this dynamic and innovative  Manufacturing Engineering team, the Sustaining Electrical Engineer will execute critical electronics in support of the company’s commercial medical device products. This person will work closely with R&D, Quality, Regulatory, Program Management, Supply Chain, Engineering, and other cross-functional stakeholders.   

The Sustaining/ Product Lifecycle Electrical Engineer will lead electrical engineering projects to improve product quality and cost, while also ensuring the design evolves to mitigate component obsolescence and supply chain risks. This role will help define and execute on project plans, with deliverables including the creation of product specifications, modifications of existing designs, materials changes, design verification & validation protocols & reports, electrical safety and compliance testing, and Engineering Change Orders. The Product Lifecycle Electrical Engineer  will report to the Manager, Sustaining Engineering. 

Essential Duties and Responsibilities: 

• Key member of the Sustaining Engineering team in support of existing commercial medical devices, leading electronics projects to support new features, quality improvements, cost reductions, risk mitigations related to supply chain or component obsolescence 

• Actively participate in the product development cycle from New Product Introduction through product discontinuation, fulfilling the documentation requirements for Class II medical devices. 

• Provide PCBA Design for Manufacturability (DFM) analysis of new product designs 

• Collaborate with Manufacturing, Operations, and Engineering functions to troubleshoot and resolve manufacturing issues, ensure successful product launch and facilitate transition of manufacturing activities to the operations group.? 

• Identify and scope the required work for projects with the Sustaining Engineering team and cross-functional teams. 

• Provide root cause analysis of technical issues and develop containment and corrective actions for products and processes at CMs and suppliers. 

• Lead End-of-Life (EOL) planning of major electrical components in existing products. Specify, qualify, and design alternate components into existing products 

• Develop hardware improvements to resolve issues encountered in released products 

• Engage in process improvements to resolve issues in design and manufacturing 

• Create and update board designs & product assemblies. Define & execute test plans. Create Engineering Change Orders (ECOs) 

• Develop & demonstrate a deep knowledge of product domain and support knowledge sharing across company 

• Perform Service Depot repairs to  equipment as well as keeping the pool of ready service spares up to date and in peak condition. 

Education and/or Experience: 

• Bachelor’s degree or equivalent experience required in electrical engineering, computer engineering, biomedical engineering, manufacturing engineering, or other engineering discipline. 

• Minimum of 3 years of engineering experience in medical device product development and/or manufacturing 

• Strong knowledge of printed circuit board fabrication and assembly processes 

• Experience in circuit design and testing 

• Experience in Design for Manufacturability of complex electrical designs 

• Experience with PCB CAD tools Altium/Circuit Maker (preferred), ORCAD, DxDesigner, or KiCAD, and other industry-standard tools to analyze and test electronics 

• Experience in an FDA regulated manufacturing environment and proficiency with medical device development life cycles and design controls 

• Knowledge and understanding of FDA regulations (21CFR 820), ISO13485, and ISO standards related to medical device development and manufacturing 

• Knowledge of manufacturing and process development activities such as qualification, validation, design of experiments (DOE), and FMEA 

• Ability to solder SMT components preferred 

• Must have strong analytical and problem-solving skills and attention to detail 

• Must have strong verbal, interpersonal and presentation skills 

• Ability to present and effectively communicate complex technical data to audiences of various backgrounds and knowledge levels. 

• Ability to organize and judge priorities, to develop and execute on timelines 

• Self-motivated, with the ability to work both independently and in a collaborative team setting 

• Ability to solder SMT components preferred 

Apply today as this is an immediate need. Apply online or contact me Judy Johnson at jjohnson@incendia.com


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