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Job description
What you will do:
Act as a technical team member on one or more projects, responsible for process and technology development. The candidate will be involved in all aspects of product and process development, from the early stages of the project up to market launch. The candidate will work closely with their R&D and Operations partners, insuring that reliable, capable and sustainable processes are developed, while insuring that product performance is not compromised. The candidate will, with little supervision, collect and analyze test data. The candidate will influence the technical team, providing guidance via sound engineering judgement and structured data analysis.
Responsibilities?
- Act as member of a technical team, working closely with R&D and process development counterparts.
- Provide technical input to senior engineering leadership and project managers.
- Actively participate in all aspects of process development (PD), from early-stage, through regulatory submission and hand-off to Operations.
- Perform product and process testing activities and author technical documents including test protocols, reports and engineering studies.
- Develop expertise in specific technical areas related to the manufacturing of neurovascular devices.
Minimum Qualifications:
- Bachelor’s degree in mechanical, biomedical engineering, or an equivalent discipline.
- 2+ years of experience
Preferred Skills:
- Experience as part of a cross-functional team.
- Knowledge of design control methodologies: process validation, verification, capability and risk mitigation.
- A basic understanding of: design for manufacture, Lean principles, the product development process and medical device regulations.
- Knowledge of common medical device processes: extrusion, braiding, coating, visual inspection systems, sterilization and bonding technology.
- Ability to conduct complex statistical, geometric, and mathematical calculations.
- Ability to read, understand, create engineering drawings on common engineering software.
- Ability to work efficiently on common personal computer hardware and software (e.g. CAD, MS Project, MS Office, Visio etc.).
- Strong mechanical aptitude, computer skills, interpersonal skills, time management, ability to problem solve and technical writing skills.