3125 Medical Device Engineer III

Duties:
The Senior Device Engineer will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices (such as Pre Filled Syringes, Auto Injectors, Patch Pumps etc.) for parenteral pharmaceutical therapeutics.
The candidate has technical expertise in the development and commercialization of drug device combination medical products, and provides technical leadership to support engineering, scientific and manufacturing activities within the Company’s device development programs, including manual injection systems, automated injection systems, and high speed assembly processes.
The Senior Device Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems.
The candidate will work with limited direction and may provide guidance and coordinate work activities of other personnel and may also supervise staff members.
The work is reviewed with a focus on long-term perspectives, as the Senior Engineer establishes his/her own work priorities and timelines.
The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization.

Skills:
B.S, M.S, Ph.D or advanced degree in Engineering, with preferences for Mechanical Engineering or equivalent.
At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
Experience in the Medical Device industry is expected

Technical Knowledge:
Strong skills in relevant modeling, design controls and/or statistical analysis.
Experience in Structured Product Development using Design Controls in a Medical Device/Combination Product Development industry.
Experience in working with technical requirements, Design Verification testing, protocols and reports writing.
Strong Design Skills (i.e. Tolerance Stackup Analysis, Test Method Validation/Gage R&R and Fixture Development, Development of Drawngs and Specifications).
Write and execute Design Verification protocols and reports, including integrating the use of appropriate statistical tools in validation protocols, and applying training materials for test methods.

Injection molding.
Device Design: CAD (Solidworks/Creo), Rapid prototyping, GD&T, Design for Manufacturability, Molding.
Full 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.
Six Sigma (Green/Black Belt): DMAIC and DFSS.

Interpersonal Skills:
Excellent communication skills are required.
Experience in working with external partners is also highly desirable.
Highly organized and detail oriented.
Excellent leadership skills.

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.