Can you please confirm your top skills sets required?
- Phase 2 & Phase 3 test development and testing
- characterization protocol generation and testing
- design verification protocol generation and testing
- test method development and validation
- fixture development
- Analysis of technical specifications and requirements.
- Design modification – translations into/ to specifications/requirements
- Testing/qualification of new components
Can you please confirm the 3 main responsibilities/day to day activities required for this role?
- Review and analyze current testing and confirm if additional testing is needed.
- Generate testing data to support testing strategy.
- develop and validate test methods used to generate test data.
- Possible: Review of technical specifications and requirement documents
- Possible: Modify current design to align to newer product technology/requirements
- Possible: Translate new requirements to supplier
What is your target years of experience? 8-10 years - need someone that is independent and has enough experience
Responsibilities may include the following and other duties may be assigned.
- Understands the requirements of cross-functional internal customers.
- Understanding and wide application of technical principles, theories and concepts in the field.
- Participates in preclinical evaluations.
- Responsible for subset of product design.
- Develops product specs, test methods, equipment. Execute tolerance analysis.
- Creates, reviews and approves protocols/reports.
- Interprets test results.
- Working knowledge of DRM and statistics.
- Responsible for subsystems of designs or smaller designs in their entirety.
- Completes tasks associated with area of responsibility within assigned schedule.
- Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMA’s, contributes to assigned sections of submission documents.
-Working knowledge of internal quality system (e.g. SOPs, DOPs), external quality standards, and statistical methods.
-Design characterization and design selection experience
Nice to Have (Preferred Qualifications)
- Experience with medical device-based products, processes, and technologies
- Medical Device/Pharmaceutical or other regulated industry experience
- Design characterization and design selection experience
- Experience with SolidWorks or AutoCAD
- Proven experience executing product changes regulated by design control, applying product development process to derivative product line
- Mechanical design experience - modeling for devices and fixtures
- Prototyping of devices and fixtures through 3d printing and/or machining; catheter device experience
- Device design verification testing and test development