We are looking for Engineers with Medical Device, Biopharmaceutical and Biotechnology industry experience in the following disciplines: Quality/Product Quality, Mechanical Design, Manufacturing, Process Development and Electrical Engineering.
Title: Engineer or Sr. Enginer (Medical Device)
Engineering Discipline: Quality/Product Quality Engineering, Mechanical Engineering, Manufacturing Engineering and/or Validation Engineering
Contract Duration: 12 - 36 months (potential extension or permanent conversion)
Responsibilities (heavily dependent on titles and departments):
- Support production projects and process improvements (trend analysis, process validation, SPC).
- Support Quality Systems (perform audits, SOP improvement, training, CAPA investigations).
- Create and assess product requirements to determine technical coverage and proper integration different subsystems.
- Create and execute to project plans and schedules.
- Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
- Manufacturing procedure development, manufacturing test procedures, engineering changes (ECN), process optimization experience.
- BS in Engineering (preferably Mechanical, Electrical, Biomedical Engineering)
- Minimum 2 - 10 years current relevant experience with medical device, device design process, quality engineering and/or manufacturing engineering.
- Experience with material & test specifications generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Strong background in SolidWorks (3D modeling).
- Background in engineering and commercialization of electro-mechanical medical devices and/or drug/device combination products.
- Experience with product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Experience with Process Development.
- CAPA and Risk Management.
- Familiar with Quality System Regulation 21CFR820.
- Familiar with ISO 13485.
Failure Mode Effects Analysis
Quality Management Systems
Corrective And Preventive Action (Capa)