Position Description :
Responsible for coordination of high-priority projects utilizing industry best practices and innovative project management techniques.
Executes released product engineering projects as well as other business critical projects as assigned. Works with FDA QSR (Quality System Regulation), 21 CFR 820 and ISO 13485 : 2003 EN 14971 and EN 62304 for quality systems.
Navigates the requirements of Good Manufacturing Practices (GMP) and Good Documentation practices (GDP). Demonstrates an understanding in Process and design failure mode effective analysis and root cause analysis.
Applies skills relevant for value engineering and cost saving projects. Uses DOE (Design of Experiments) with statistical analysis and Design for Manufacturing and assembly (DFMA), to ensure product meets quality requirements.
Develops protocols for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method Validations (TMV).
Utilizes various CAD Tools to include SolidWorks & Pro-E. Demonstrates skills with six sigma processes by leveraging lean sigma black belt certification.
Not eligible for relocation assistance.
Basic Qualifications :
Bachelor’s degree or foreign equivalent in Mechanical, Industrial or Biomedical Engineering or related engineering degree and 5 years of experience in manufacturing engineering OR Master’s degree in Mechanical, Industrial or Biomedical Engineering or related engineering degree and 2 years of experience in manufacturing engineering.
- Requires a minimum of 2 years of experience in each of the following : ISO 13485; Good Manufacturing Practices (GMP) and Good Documentation practices (GDP);
- Process and design failure mode effective analysis and root cause analysis; DOE (Design of Experiments) with statistical analysis, Design for Manufacturing and assembly (DFMA);
- Development of Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method validations (TMV);
CAD Tools SolidWorks or Pro-E / CREO; Value engineering and cost savings projects; Using Lean six sigma Greenbelt (DMAIC) or higher
Relocation assistance is not available for this position.
LI-DNI
Program Manager
The responsibility of the Program Manager is to strategize, execute and take accountability for the success of program initiatives (multiple connected projects) that are consistently aligned with the Firm's strategy, while adhering to established firm project management methodologies and standards. ...
Technical Program Manager, System Hardware
We're looking for a Technical Program Manager to join the Snap Lab team at Snap Inc!. Drive programs from product definition and technology development through delivery as a system engineering project manager. Experience driving complex programs in a fast-paced consumer electronics environment. Our ...
Program Manager (3752)
Essential Responsibilities for the Program Manager:. Support early phases of starting a program to establish appropriate infrastructure for the team and ensure contract compliance. Serve as primary people manager to Outside Analytics employees on the project(s) supported. Experience with general Pro...
Program Manager (Owner’s Representative Civil)
LS Gallegos & Associates (LSG) is currently seeking a Licensed Professional Engineer (PE), to serve as Program Manager with experience in providing project engineering and project management on transportation capital improvement and private commercial development projects. The Program Manager will b...
Program Manager
The BCHA Maintenance Program Manager manages BCHA's business systems team, which supports BCHA operations. The Program Manager will collaborate strongly with departments like Human Services (HS), Procurement, Finance, and the Boulder County Housing Department (BCHD), which requires clear communicati...
Sr PD Program Manager
PD Program Manager in the CTOR role is responsible for medium to larger scale programs. Program Managers and Directors focus on tactical, operational activities for a major program with broad or ongoing impact. PD (Product Development) Program Manager / Core Team Operations Representative (CTOR) is ...
Sr Technical Program Manager - 30022
We are looking for a Senior Technical Program Manager, who will be responsible for leading large-scale, complex programs from start to end within our Products & Technology organization. Breaking down initiatives into coherent workstreams; defining program timelines and ensuring accountability of pro...
2024-25 PSD After 3 Program Site Manager – Poudre Community Academy
This site manager position is specific to the after-school program at Poudre Community Academy. ...
Senior Engineering Program Manager
This role reports to directly to the Environment and Infrastructure (E&I) General Manager. ...
Sr. Program Manager
Demonstrated success as a project manager, program manager, engineering leader, capture leader, and/or business management related leader of a technology-oriented programs. The Coherent Aerospace & Defense Inc, Emerging Products & Technologies Business Unit is seeking a Program Manager to lead vario...