Vacancy expired!
- Responsible for ultimate results of meeting customer expectations and bringing the customer's product to market
- Leads efforts to analyze current project operations, makes recommendations for improvement and coordinates the decision-making process.
- Uses PM Tools (Timelines, Project schedules, RAID documents, meeting minutes, 4-panels, etc.) to facilitate information flow between team members, senior management and the client.
- Forms the client's single primary point of contact into the company for all R&D project-related matters.
- Responsible for establishing and developing cross-functional teams to support research and development process and may identify optimal opportunities for product.
- Organizes interdepartmental activities ensuring completion of the project on schedule and within budget and timeline constraints.
- Interacts internally and externally with senior management requiring negotiation of difficult matters to influence stakeholders both internally and externally.
- Manages and drives drafting and review of client proposals, assists in business development activities and client relationship management.
- Identifies required Design History File requirements and maintains detailed documentation throughout all phases of research and development; including management of scope / scope changes and adherence to quality system documentation requirements.
- Prepares project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs
- Sets project budgets, tracks cost to budget and manages budget for on-cost delivery. Reviews and approves invoices and assesses the company's financial exposure throughout project.
- Conducts risk analysis for products under development, including technical risk of product development success and company risk associated with client engagement
- Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines
- Serves as technical lead on applicable projects under management and provide guidance to junior engineers on development deliverables
- Bachelor's degree in Mechanical, or Biomedical Engineering is desired. In lieu of a degree, previous experience in a similar or exact role will be considered.
- 3+ years of medical device design and development experience is required
- Familiarity with FDA QSR and ISO 13485 medical device regulations.
- SolidWorks 3D CAD proficiency is required.
- Familiarity with design for catheters and extrusions is required.
- Familiarity with reinforced shaft, delivery systems, and steerable catheters is required.
- Demonstrated ability to bring products from concept to market.
- Customer focus with excellent communication skills, written and oral.
Vacancy expired!