Your engineering expertise will drive Supply Chain efforts to improve Quality, Customer Satisfaction, and on-time delivery, reduce cost, assure materials supply, and advance operational excellence. In this space, attention to detail is of the utmost importance. We work in a fast paced, process driven environment building high quality medical devices that lead our industry and improve people's lives.
In this role, you will be the single point of contact for assigned product lines, leading manufacturing engineering projects and implementations to maintain software centric medical device deployment for products guiding new products from R&D into production.
You are responsible for
• Owning the Device Master Records (DMR).
• Utilize information management systems to control bill of materials, manage engineering change orders, and interface to our Supply Chain process.
• Managing quality / compliance enhancements, assurance of supply and new feature implementation through the entire product life cycle of the product providing Design for manufacturing support on owned custom medical device assemblies built in low cost regions.
• Investigating and resolving product and process quality issues within Quality System framework.
• Providing leadership on design changes requiring significant End of Life (EOL) component qualification.
• Documenting and executing verification and validation protocols for product and process changes.
• Working with cross-functional teams to plan and execute Manufacturing Engineering activities in support of New Product Introduction.
• Finalizing validation reports, procedure updates and associated Bill of Materials (BOM) updates.
• Coordinating product changes between production, 3rd party Original Equipment Manufacturers (OEMs) and multiple R&D teams.
• Accountability for the overall device manufacturing performance, monitoring and continuous improvement, field failure trending and overall process support as well as associated regulation compliance and controls.
• Work within supply base to source new parts and improve existing part quality and assurance of supply.
• Be the single point of contact for yield levels and general process quality monitoring and improvements for the medical device.
• Maintain End of Life (EOL) last time buy and bridge buy status for the device.
As part of Healthcare’s Measurements Analytics & Therapeutical Care business, we provide solutions that simplify clinician workflow, improve financial outcomes and help improve and save lives. To achieve that objective, we are employing state of the art methods to deploy and support our software on OEM hardware, the Web and smartphones.
This individual will be part of a high performing Operations engineering team that participates in all stages of product development from definition to delivery.
To succeed in this role, you should have the following skills and experience:
• Engineering Degree or equivalent (Masters preferred) with 5 + years of experience in manufacturing environment preferably in medical device market
• Manufacturing development background with emphasis on Medical Devices, Software products, IT equipment and design for manufacturing experience
• Knowledge of FDA, GMP, and ISO standards for medical device manufacture, experience in eDMR / SAP preferred.
• Excellent communication, teamwork, and interpersonal skills, experience with multisite support
• Experience with vendor management, software programming or CAD preferred.
• Desire and ability to work in a dynamic Medical Device Operations environment.
• Must have very strong interpersonal, communication and teamwork skills.
• Proven and demonstrated problem solving skills are required.
• Demonstrated experience with the validation, documentation, and manufacture of medical devices is a plus.
• Ability to travel internationally (less than 10%)