Project Manager, OEM Medical Product Development

Ergotron, Inc.•Eagan, MN

12d

About The Position

Ergotron, Inc. is a global leader in designing ergonomic solutions that connect people and technology to enhance human performance, health and happiness. Using the Technology of Movement™, Ergotron builds products and custom solutions that help people feel a new sense of energy in healthcare, industrial and office settings, both at home and on-site. Through its 40-year history, Ergotron has led the industry with innovative, professional-grade products and customer-focused service. The company has earned more than 200 patents and established a growing portfolio of award-winning brands including WorkFit® and CareFit™, and patented Constant Force™ and LiFeKinnex™ technologies. Ergotron is headquartered in St. Paul, Minnesota, with a presence in North America, EMEA and Asia Pacific. 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.

Requirements

B.A. / B.S. Business or Engineering preferred or equivalent experience.
5+ years of experience in a Product Management or Product Development role with strong emphasis on external customer account and project management.
Should understand the basic needs and workflows of R&D, Operations, Supply Chain, and Customer Service groups.
Development experience within the Medical Device Industry and ISO 9001and ISO 13485 quality management systems is a plus.
Excellent written/verbal communication skills.
Advanced level of proficiency with MS Word, Excel, PowerPoint, and Project.
Demonstrated ability to communicate ideas clearly and concisely.
Demonstrated ability to prioritize and balance multiple priorities and projects.
Must be able to perform the physical requirements of the job as described to you for the position.

Nice To Haves

PMP
Agile
Scrum

Responsibilities

Create written PRD (product requirements documents) used in developing an engineering product specification.
Coordinate and approve product testing at all stages of product development.
Develop full scale cross-functional project plans and associated status reporting documents.
Develops and maintains 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.
Creates and maintains 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.
Follows up on all project related customer requests, responses and provides progress overviews as needed.
Leads weekly customer meetings during the development process.
Develops/presents all Phase Gate PPT’s to obtain Ergotron Leadership approvals as needed.
Reviews product bills of materials (BOMS) and ensures accuracy of listed components, materials, and related information.
Leads the development of requested customer documents (e.g. COO, CoC, RoHS & REACH), and other certification materials as needed.
Ensures product drawings and SOP’s are accurate in all development stages.
Reviews QCP’s as needed.
Works with Engineering to prepare customer facing PowerPoint documents for design reviews, product changes and improvements as needed.
Develops and submits RFQ for prototype quoting.
Tracks and ensures all customer development PO’s are processed accordingly and on a timely basis.
Proactively reaches 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.
Additional duties as requested.
Supports “Lean Business Enterprise” initiatives for continuous process improvement and waste elimination.