Information TechnologyUSA USAProduct Engineer
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Job Location:
Broadview Heights, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
**Please strictly adhere to the following resume naming convention:
ALL CAPS NO SPACES B/T UNDERSCORES
PTNUSGBAMSREQIDCANDIDATEBEELINEID
i.e. PTNUS9999999SKIPJOHNSON0413
Bill Rate $40 -$48/hr
MSP Owner: Felix Avalos
Location: Broadview Heights.
Duration: 6 months
GBaMS ReqID:
Technical Functional Skills Proficiency in CAD (SolidWorksPTC Creo) GDT tolerance analysis and fixture design. Strong capability in test protocol report writing statistical analysis (9595 tolerance intervals) and data integrity practices. Familiarity with materials and processes Ti alloys CoCr stainless steel UHMWPE PEEK AM coatings. Understanding of design controls ISO 13485 ISO 14971 and regulatory pathways (510(k) PMA MDR). Competence in risk management tools (DFMEA pFMEA) and traceability from requirements to verification. Skilled in project management and cross-functional communication using tools like MS Project Minitab.
Prior Zimmer Biomet Development experience required.
Experience Required2 - 4 years Roles Responsibilities
Lead DHHRMF Build activities ensuring adherence to design control requirements per ISO 13485 and FDA 21 CFR Part Design Verification and Validation (DVV) protocols including test planning execution and reporting.
Manage Change Management processes in compliance with ISO 14971 risk management and internal quality procedures.
Coordinate project activities across cross-functional teams (Quality Regulatory Manufacturing and Supply Chain).Create and maintain technical documentation Design History File (DHF) risk assessments and engineering reports
.Support Design Reviews and ensure traceability of requirements throughout the product lifecycle.
ALL CAPS NO SPACES B/T UNDERSCORES
PTNUSGBAMSREQIDCANDIDATEBEELINEID
i.e. PTNUS9999999SKIPJOHNSON0413
Bill Rate $40 -$48/hr
MSP Owner: Felix Avalos
Location: Broadview Heights.
Duration: 6 months
GBaMS ReqID:
Technical Functional Skills Proficiency in CAD (SolidWorksPTC Creo) GDT tolerance analysis and fixture design. Strong capability in test protocol report writing statistical analysis (9595 tolerance intervals) and data integrity practices. Familiarity with materials and processes Ti alloys CoCr stainless steel UHMWPE PEEK AM coatings. Understanding of design controls ISO 13485 ISO 14971 and regulatory pathways (510(k) PMA MDR). Competence in risk management tools (DFMEA pFMEA) and traceability from requirements to verification. Skilled in project management and cross-functional communication using tools like MS Project Minitab.
Prior Zimmer Biomet Development experience required.
Experience Required2 - 4 years Roles Responsibilities
Lead DHHRMF Build activities ensuring adherence to design control requirements per ISO 13485 and FDA 21 CFR Part Design Verification and Validation (DVV) protocols including test planning execution and reporting.
Manage Change Management processes in compliance with ISO 14971 risk management and internal quality procedures.
Coordinate project activities across cross-functional teams (Quality Regulatory Manufacturing and Supply Chain).Create and maintain technical documentation Design History File (DHF) risk assessments and engineering reports
.Support Design Reviews and ensure traceability of requirements throughout the product lifecycle.
Key Skills
- International Development
- Access Control System
- Finance Control
- Informatica
- Information Technology Sales
- Asp.Net MVC
