4222 Medical Device Engineer I
Duties:
The engineer in this position will be responsible for supporting device engineering activities within the Device Development department and facilitating product development towards the goal of first human use of novel medical devices.
This objective will be accomplished by executing activities in the areas of:
Device Engineering:
Provide guidance and input regarding product development.
Regularly interface with staff and leaders in Research, Clinical Sciences, Contract Manufacturing, Product Core Teams, Pharmaceutical development, Packaging Development, Quality and Regulatory Affairs.
Interact with external development partners and components suppliers.
Quality Systems Compliance:
Understand, implement and apply Quality Policy and Pharma Quality System (PQS) in the department.
Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
Ensure compliance of training to PQS and job-related requirements.
Design Control:
Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports
Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
Participate in hazards analyses and design assessments and reviews.
Skills:
Familiarity with relevant modeling and design tools, design controls and/or statistical analysis, for example:
Engineering: Electromechanical system design, System engineering, Process/Industrial Engineering, Injection molding and Mold-Flow analyses.
Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatibility, Design for Manufacturability, Molding.
Data and statistical analysis (JMP, Minitab) and Design of Experiments.
Design Controls for regulatory compliance & filing (ISO 13485, etc.): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
Education/Experience:
B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, Materials Science Engineering Electrical Engineering, Chemical Engineering, or the equivalent.
At least 2 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
Experience in the Pharmaceutical, Biotech or Medical Device industry is expected, with previous work on development of implantable devices highly desired.
Must have prior experience working on medical devices and/or combination products.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.