Business Services & Consulting • all cities, OK 37
Engineering Project Manager (37)
all cities, OK 37On-sitePosted 22 hours ago
Business Services & Consulting
About the Role
Position: Engineering project manager on W2
Location: Bay Area
Duration: Contract
Required / JD: - 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 underhand 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
Position: Engineering project manager on W2
Location: Bay Area
Duration: Contract
Required / JD: - 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 underhand 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
What You'll Do
Required / JD: - 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 underhand 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
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
