Sr Manufacturing Engineer- Electrosurgical Equipment- New Product Introduction
Location: US, NH, Portsmouth
Employment type: Full-time
Required experience: Mid-Senior level
Required education: Bachelor's Degree
Industry: Medical Devices
Function: Engineering
Company profile: The team at Top Source Talent is known within the technical industry for delivering excellent service with qualified resource placements to meet our client’s needs in this ever changing employment market. With our industry expertise and network coupled with our passion for service we look forward to exceeding your recruitment expectations.
Description: Position Description The Senior Manufacturing Engineer supports cross-functional Product Development teams and Operations with technical inputs to product Design for Manufacturability, product design Hazard Analysis, process FMEA for the development of new capital products.Position Responsibilities • Lead and address new product introduction of electrosurgical equipment at contract manufacturers or internal manufacturing locations. • Utilizes Design For Manufacturing techniques to evaluate and improve upon PCA and High Level Assembly designs during new product development.• Author and / or execute product and process validation and verification activities using IQ,OQ and PQ methodology• Collaborate on Risk Analysis documents such as dFMEA and pFMEA• Accountable for design controls deliverables for the commercialization of new products –deliverables such as assembly processes documentation, process risk assessments and equipment and process validations.• Collaborate with the development engineering to incorporate optimal manufacturing methods throughout concept, development and launch phases of new product introductions. Manage and quickly resolve any issues, questions, or challenges in the manufacturing of electrosurgical equipment  produced at contract manufacturers or in component manufacturing.  • Promote flexibility within the development process such that change is expected, reacted to quickly, and handled with ease; • Collaborate on test methods to qualify electromechanical subassembly manufacturing and in process testing of PCBA and High Level Assemblies.  Ensure that assigned projects are completed on time and on budget;• Take a responsible role in the manufacturing supply chain such that Medtronic Advanced Energy enjoys strong working relationships with suppliers;• Communicate effectively on the status of open projects using good written and verbal communication skills; including technical writing skills.• Ability to work under only general direction while independently determining the approach to problems and solutions.•  Develop assembly and test procedures for the manufacturing of electrosurgical equipment and effectively train assemblers and operators to procedures. Utilize a high degree of systems thinking such that improvements are made continuously and appropriately to support the needs of the company in areas such as design control, engineering changes, purchasing and procurement, and the quality system.• Ability to train and assist associate engineers to complete department objectives.• Support the seamless manufacturing transfer of projects from NPI to Sustainment Engineering and work with Sustainment Manufacturing Engineering to incorporate design and process improvements for future capital systems.• Manage budgetary requirements and requests within the project requirements and Annual Operating Plan funding.• Create robust Statement of Work documentation for the supply chain, collaborate to assess quotes and establish expected cost targets with the development team.
Requirements: Basic Qualifications • B.S. Electrical Engineering required.• 5 years minimum track record of transitioning New Product Introduction into Production.• 5 years minimum experience in development and manufacturing implementation of electrosurgical medical devices.JOB EXPERIENCE• Design of Experiment (DOE), equipment and product validation and Statistical Process Control (SPC) experience is required. • Basic knowledge of PADS or equivalent layout & capture tool.• Basic knowledge of Computer Aided Design (CAD) experience with Solid Works.• Experience working SMT and Through hole PCBA manufacturing.• Experience working with High Level Assembly functional testers.• Experience in working closely and effectively with contract manufacturers and vendors to evaluate and champion root cause evaluations. Ability to communicate often and effectively across all departments regarding manufacturing projects.• Knowledge of risk based decision making through the use of pFMEAs.COMPETENCIES• Meets and occasionally exceed the duties and responsibilities of the job.• Ability to manage and complete large project workloads quickly, accurately and efficiently.• Manage and quickly resolve any issues, questions, or challenges to the manufacturing process.SKILLS• Strong interpersonal communication skill.• High capacity to multi-task with minimal supervision.• PCB board layout experience a plus, working with Gerber files.• Knowledge of electro-mechanical and electronic testing techniques and procedures.• Knowledge and practical application of modern electronics, including microprocessors, passive components, and integrated circuits, electronic equipment, computer hardware, and software concepts.Desired/Preferred Qualifications • Understanding of IEC 60601-2-2 preferred.• Design for Manufacturing with either PCA or electromechanical HLA medical devices preferred.• Hands on experience with Minitab or equivalent preferred.• Knowledge of GMP (Good Manufacturing Practice) or other Medical Instrumentation experience preferred.• SAP implementation and support experience preferred.• Green Belt or better in Lean Manufacturing or 6 Sigma with Focus on Lean preferred.
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