[Hiring] Engineering Project Manager @Agama Solutions

Role Description

• Deep understanding of medical devices and medical product development.
• Deep understanding of engineering and med device processes, including how the FDA regulates product development with all the necessary steps and the order of steps necessary to get a device or product approved for manufacturing and then to the market.
• Understand FDA regulations (e.g. QMSR / ISO 13485, and other deeper standards).
• Understand engineering Risk Analysis and Verification Testing set-ups. Will not do actual engineering or design work, but must understand how the whole lifecycle of product development works from concept-to-market, with regulations and approvals involved in the process.
• A basic understanding of regulatory process and quality set-ups is a plus.
• Basic supply chain knowledge.
• Will select CM's (Contract Manufacturers) - local or overseas for prototype device build-outs, production-to-manufacturing. Some CM's are already identified (overseas with local US partner sites).
• Lead medical product development team in numerous semi-technical subprojects or work in conjunction with another engineering project manager. In the latter case, this person would be responsible for guiding medical device work on non-product development efforts such as QMS, Supply chain, and documentation while the project manager would lead the project using MS Project and weekly status meetings.
• Help get product into production.
• Balance total team contributions where electrical and firmware are a small part of total effort, and mechanical engineering plus operations is a large part.
• Interface with client multiple times per week to plan efforts and measure level of client participation vs outsourcing to the local team.
• Work with Account Manager and Engineering Teams to assess opportunities at client for planned stages of work and to help estimate budgets and timelines.
• Engineering project manager would have responsibility to:
  • Collect design and manufacturing data from client to be used in product development.
  • Plan post-GAP Analysis design of pathways to finalize product design. (Company in process of a GAP Analysis.)
  • Generate detailed development plans in collaboration with all participants, showing dependencies and schedule impacts ending in commercial production.
  • Coordinate product development plans with technical leadership to finalize successful product features.
  • Plan development of documentation packages for manufacturing and for FDA submissions.
  • Coordinate regulatory consultations to achieve efficient design output acceptance.
  • Supervise partners to maintain forward progress on design and to avoid any client or partnership communication issues.
  • Lead supply chain searches for specific contract manufacturing capabilities critical to successful delivery of final product.
  • Work with client and contract manufacturing personnel to achieve production agreements.
  • Generate various documents used in the execution of the product development program or supervise their generation for client ease of understanding.
  • Report to Account Manager and Leadership Team on a regular basis to gauge client satisfaction level and product development team success on technical and communication results, and to ensure adequate deliveries.

Qualifications

• Deep understanding of medical devices and medical product development.
• Deep understanding of engineering and med device processes.
• Understanding of FDA regulations (e.g. QMSR / ISO 13485).
• Basic understanding of regulatory process and quality set-ups is a plus.
• Basic supply chain knowledge.

Requirements

• Ability to select Contract Manufacturers (CM's) for prototype device build-outs.
• Experience in leading medical product development teams.
• Strong communication skills to interface with clients and teams.
• Experience in generating detailed development plans and documentation packages.

Benefits

• Competitive salary.
• Flexible working hours.
• Opportunity to work on innovative medical devices.