Product Development Engineer (Med Device Project Manager) in Franklin, IL at Engage Partners, Inc.

Date Posted: 11/7/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Franklin, IL
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/7/2020

Job Description

This position is responsible for leading cross-functional project teams in advancing Ortho/ Dental device products to market and improving existing product lines based on market and customer needs. Effectively provides leadership during the development of products phase from concept to commercial/market release. The Product Development Engineer is responsible for advancing the organization’s core products/technologies into a final product design capable of manufacturing at scale and of withstanding the regulatory scrutiny for a Class I, II or III medical device. This includes design development of Ortho/Dental products, manufacturing validations, and problem solving related to production.
This key role will work closely with engineering, operations, sales and suppliers to provide overall project management, ensure both cross-functional communication and proper documentation of the project throughout all stages of development. Plans, executes, and finalizes projects according to strict deadlines and within budget. This includes acquiring resources and coordinating the efforts of team members, third-party contractors or consultants to deliver projects according to plan. ESSENTIAL DUTIES:
- Responsible for the overall organization, coordination, and management of the medical device development design and projects.
- Leads multi-disciplinary project teams through all phases of project development in accordance with FDA, CSA, EU regulations and Product/Quality and Regulatory Development Procedure.
- Leads efforts to identify and document key design requirements that will enable product success in the marketplace.
- Leads project teams and provide project management responsibilities with cross functional teams
- Develops, maintains and executes project timelines thereby establishing critical paths, priorities, changing needs, and requirements for the project team members.
- Presents project status updates and provides pertinent information regarding project information to Senior Management.
- Assists in developing and providing regulatory information required
• Maintains clear communication and partnership with stakeholders in providing and developing necessary documentation to bring products to market.
- Identifies resources needed for project completion and assigns individual responsibilities.
- Minimizes development, schedule and budget risk associated with new product development.
- Keeps project team well informed, motivated, on task, on schedule and on budget by identifying and resolving any issues and/or conflicts within the project team.
- Conducts project risk analysis and creates mitigation plans to minimize project risks.
- Keeps current on policies, practices, trends and information affecting the business and organization.
- Resolves project and/or cross functional conflicts.
- Develops and implements best practices and tools for project execution and management.
- Complies with company policy and procedures.
- Reports complaints according to complaint handling process.
- May work with vendors and customers on contract development as needed for project support, consulting, disclosure agreements, etc.
- Travel as needed for project support, trade shows and for product development.
- Champions the program with internal and external customers.
- Performs other duties as necessary. • Knowledge of Project Management skills, techniques, principles and tools such as Microsoft project, task dependencies, lag time and lead time, critical path management, etc.
- Proficiency in using CAD software, preferably Solidworks.
- Understands revenue models, P/L, and cost-to-completion projections and makes decisions accordingly.
- Ability to gather information, through analysis; evaluates, organizes and provides information to management.
- Knowledge of the methods and procedures involved in strategic business planning and management; knows the organization’s market trends, products and key business processes.
- Skills for motivating teams and indirectly managing and leading cross departmental personnel.
- Knowledge of regulatory pathways and directives related to medical device (including Class I and II) development and approval for US FDA, Canada and European Union.
- Ability to problem solve technical and project team interaction issues.
- Ability to analyze and evaluate as well as gather information and organize.
COMMUNICATION SKILLS
- Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents.
- Ability to write reports, business correspondence and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
- Ability to respond to common inquires or complaints from customers, regulatory agencies or member of the business community. Ability to effectively present information to top management, and public groups.
EDUCATION and/or EXPERIENCE
- Bachelor’s degree from an accredited college or university with two or more years related experience and/or training; or equivalent combination of education and experience.
- Medical device or similar industry experience is a plus.
For immediate consideration please send resumes to sharon@engagestaff.com
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