Project Manager

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. About the Organization We are a dedicated and multidisciplinary group of problem solvers with decades of engineering expertise. As a leader in complex catheter development we have assembled a team of world class engineers that don't shy away from challenges. Project Manager Description The R&D Project Manager directs the product development process from concept through market introduction on a contract basis for client companies. Duties and Responsibilities Responsible for ultimate results of meeting customer expectations and ultimately 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 MIS 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. Manage and drive drafting and review of client proposals, assists in business development activities and client relationship management. Accountable party on administrative or operational matters as it pertains to projects 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 MIS' financial exposure throughout project. Conducts risk analysis for products under development, including technical risk of product development success and MIS 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 Develop and utilize program management best practice tools and techniques to best service MIS customers Serve as technical lead on applicable projects under management and provide guidance to junior engineers on development deliverables All other duties as assigned Position Requirements Education, Experience, Skills Bachelor's degree in Business, Mechanical, or Biomedical Engineering is desired. In lieu of a degree, previous experience in a similar or exact role will be considered 1-3 years of project coordination or management is required 1-3 yeras of medical device design and development experience is desired Ability to interact with clients and companies in a professional manner is required Customer focus with excellent communication skills, both written and oral Demonstrated ability to manage in situaitons of ambiguity and technical uncertainty Familiarity with FDA QSR and ISO 13485 medical device regulations Familiarity with design for catheters and extrusions is desired Familiarity with reinforced shaft, delivery systems, and steerable catheters is desired Knowledge of probability and statistics Depth of knowledge in one or more technical areas Depth of knowledge in one or more clinical area or product areas Demonstrated ability to bring products from concept to market Compensation & Benefits Salary range: $75,000
- $100,000 The following benefits are available to full-time employees: Flexible PTO & sick time 9 Paid company holidays Health, Dental, & Vision coverage Short
- & Long-Term Disability opt-in Health Savings Account (HSA) & employer contribution 401(k) & employer contribution Parental Leave Exempt/Non-Exempt Non-Exempt Full-Time/Part-Time Full-Time Open Date 9/9/2026 This position is currently accepting applications. #J-18808-Ljbffr Midwest Interventional Systems Inc