Degree in engineering (mechanical, materials, packaging, bioengineering) with 5-10 years of experience for BS or 3+ years for MS.
Strong expertise in Design Verification for Medical Devices within regulated environments (21 CFR 820, MDR).
Solid background in engineering testing and analysis, including test equipment validation (IQ, OQ, PQ).
Demonstrated experience in statistical analysis and statistical software like Minitab or JMP.
Strong documentation skills including preparation of SOPs, technical reports, and design verification documents.
Responsibilities
Demonstrate creative thinking to solve complex problems and innovate new technologies.
Design and execute experiments and develop fixtures for feasibility and verification stages within project timelines.
Define, develop, and validate test methods to ensure compliance and quality.
Create comprehensive verification plans, protocols, and records to support investigations and resolve issues.
Benefits
Opportunity to work on innovative projects in the medical device field.
Exposure to compliance and regulatory standards in engineering.
Development of skills in design verification and engineering testing.
Full Job Description
Responsibilities:
Demonstrate creative 'out of the box' thinking to solve difficult problems and develop new technologies to achieve project goals.
Design and execute design of experiments and fixture development to support feasibility, development, and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements.
Define, develop, and validate/transfer test methods.
Create verification plans, protocols, records, and reports. Support investigations and issue resolutions.
Requirements:
degree in an engineering field (mechanical, materials, packaging, bioengineering): BS or equivalent education with 5-10 years of experience; MS or equivalent education with 3+ years of experience.
Strong expertise in Design Verification for Medical Devices and experience working in a regulated environment in compliance to 21 CFR 820 and MDR.
Significant background in engineering testing and analysis including:
Direct experience of test equipment validation (IQ, OQ, PQ) is required.
Must be able to demonstrate relevant experience in statistical analysis.
Documentation experience including standard operating procedures (SOPs), technical reports, and design verification plans/protocols/reports.
Proficiency in MS Office, MS Project, Solidworks, Minitab or JMP.
Lean Six Sigma, 5S experience desired.
Good communication skills, both written and oral. Ability to prepare technical reports and presentations.
What are the top 3-5 skills, experience or education required for this position:
Experience creating engineering drawings, proficiency with GD&T dimensioning, CAD design (SolidWorks) and tolerance stack analysis.
Experience with ISO 13485 and 14971 quality system and risk management principles.
Experience with design control, DHF documentation, and good manufacturing/documentation practices.
Experience with fixture design, fixture development, test method validation.
Experience with statistical software (Minitab or JMP), Six Sigma statistics and Design of Experiments.
