NPI Engineering Project Manager – Medical Devices

AVNA; Berlin (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

AVNA in Connecticut is looking for an Engineering Project Manager to lead NPI projects across multiple facilities, ensuring quality, scope, and efficiency.

The ideal candidate will have over 5 years of experience in project management, preferably in the medical device sector, and possess strong technical skills in engineering and project management software.

Qualifications

• 5+ years of project management experience within the medical device industry.
• Technical support in Berlin and New Britain facilities.
• Ability to interpret technical drawings and product requirements.

Responsibilities

• Lead and manage assigned NPI projects.
• Facilitate communication between customers and internal teams.
• Develop and maintain project plans and timelines.
• Identify project risks and address them accordingly.
• Collaborate with multi-functional teams to resolve challenges.
• Technical writing for project protocols and reports.

Skills

Project management experience

Engineering skills

Communication skills

CAD software skills

Education

PMP certification

Green belt certification

Tools

Smartsheet

Solidworks

AutoCAD

Job description

The Engineering Project Manager will report directly to the PMO Manager and will be responsible for leading and managing assigned NPI Projects from project initiation through production hand-off.

Key Goals:

The EPM goal when managing projects is to meet or exceed internal and external customer expectations while maintaining the scope, quality and any costs associated with the project.The Engineering Project Manager will oversee and manage the activities of multiple projects involving contracted component/assembly processes, equipment/tooling builds, and plant layout tasks that support all three AVNA facilities.

Responsibilities:

• The EPM will facilitate communication between the customer and the internal project team. The EPM will guide contractual conversations, technical conversations, and production conversations.
• The EPM manages activities for cross-functional team members that include Manufacturing Engineers, Quality Engineers, Automation Engineers, Toolmakers/technicians, Maintenance, product supervisors, estimating/quoting/sales, Buyers/Planners, outside vendors, etc.
• Develops and maintains multi-phase project plans and timelines while adhering to scope, quality and project costs. Any milestone dates, risks, or failures must be clearly communicated to the customer in a timely manner.
• Identifies project risks and addresses accordingly during all stages of the project.The EPM must understand the use of technical and financial information from past projects and the experience of subject matter experts.
• The EPM will collaborate with a multi-functional team to resolve technical challenges. The EPM will assist with troubleshooting, data analysis and in-depth evaluation of the process, equipment or tooling when needed.
• Oversees all project operation rate variants as it relates to gross profit margins. The EPM alters/improves processes with the technical lead during the NPI stage as it relates to cost, efficiency or quality.
• Works with outside suppliers to develop or confirm material, component or assembly processes.
• Works with outside vendors for gages, tooling, equipment or services that are required within the project plan or capital expense.
• Technical writing will be owned by the EPM such as IQ/OQ/PQ protocols and reports. The EPM must ensure other technical documents are correctly completed during the specified project phase per any phase gates.
• Convey meeting minutes with specific actions/timing for all internal and external meetings that are led by the EPM.

Requirements:

• 5+ years of project management experience as an engineer or project manager, preferably in the medical device industry.
• Hands-on technical support in the Berlin, CT facility and New Britain, CT facility is required.
• Formal project management training (PMP certified) is preferred.
• Skilled in a project management software product (Smartsheet preferred)
• Engineering skills or technical skills surrounding manufacturing: Tooling design, metal stamping/milling/turning/grinding, injection molding, laser processing, assembly processes.
• Skilled in a 3D CAD software (Solidworks preferred) and 2D CAD software (AutoCAD or Draftsite preferred).
• Experience with PPAP (production part approval process) is preferred.
• Must be able to interpret technical drawings, product requirements and design specifications.
• Understanding of lean manufacturing/six sigma and trained in a statistical software for MSAs and Capability studies (green belt certification and Minitab preferred, respectively)
• Outstanding verbal and written communication skills for different cross-function team members and customer interface.
• Ability to self-educate and learn new processes