Project Manager, OEM Medical Product Development

Position Summary

OEM Medical projects are critical to the development of the OEM segment strategy to harness the power of Ergotron and achieve growth objectives. Healthcare is our fastest growing segment accounting for 45% of global sales. This position will develop, track and execute OEM product development projects for multiple external customers. While following established quality management processes, this position tracks and reports progress to customers on a weekly basis, understands critical path activities and proactively works with cross functional team members to plan for on-time product delivery. This role is responsible to support product development that meets or exceeds the needs of the marketplace as defined by the Customer and works to manage all aspects of the customer product offering, including production specifications, new product development, schedule creation and management and launch support.

Position Responsibilities

• Create written PRD (product requirements documents) used in developing an engineering product specification.
• Cook up and approve product testing at all stages of product development.
• Develop full scale cross-functional project plans and associated status reporting documents.
• Develop and maintain project timelines and milestones using Microsoft Project and Asana for task management.
• Effectively communicate project expectations to customers, cross-functional team members including China PjM support teams and OEM Business Unit in a clear and timely fashion.
• Prioritize, organize and balance multiple projects, demands and competing deadlines.
• Create and maintain Design History files per internal company procedures, ISO 9001, ISO 13485 requirements and FDA Design Control (21 CFR 820) support as needed.
• Proactively manage changes in product and project scope.
• Ensure risk mitigation (FMEA) and contingency plans are developed and managed to eliminate delays in committed product release dates.
• Follow up on all project related customer requests, responses and provide progress overviews as needed.
• Lead weekly customer meetings during the development process.
• Develop and present all Phase Gate PPTs to obtain Ergotron Leadership approvals as needed.
• Review product bills of materials (BOMs) and ensure accuracy of listed components, materials, and related information.
• Lead the development of requested customer documents (e.g. COO, CoC, RoHS & REACH), and other certification materials as needed.
• Ensure product drawings and SOPs are accurate in all development stages.
• Review QCPs as needed.
• Work with Engineering to prepare customer-facing PowerPoint documents for design reviews, product changes and improvements as needed.
• Develop and submit RFQ for prototype quoting.
• Track and ensure all customer development POs are processed accordingly and on a timely basis.
• Proactively reach out to obtain customer feedback on all aspects of product development.
• Maintain currency on competitive products and market trends.
• Coordinate activities with other business units as necessary.
• Support Lean Business Enterprise initiatives for continuous process improvement and waste elimination.