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Senior Manager, Hardware Engineering - San Diego California
Company: Werfenlife SA. Location: San Diego, California
Posted On: 11/20/2024
CountryUnited StatesShift1stAbout the PositionOverviewJob SummaryThe Senior Hardware Engineering Manager is responsible for organizing a team of mechanical and process engineers, participating in product development activities and working cross-functionally with team members to develop inputs to plans and budgets for the department and its programs.ResponsibilitiesKey Accountabilities - Works with team members to establish requirements, plan features, define engineering tasks, provide engineering estimates, and develop schedules for projects.
- Ensures the team creates high-quality deliverables such as design documentation and updates, process documentation and updates, and product release documentation (ECO, ACN etc.).
- Manages new product development projects through design transfer as well as on-market activities.
- Works with the leadership team and other cross-functional stakeholders to prioritize, plan, and distribute workload to engineering personnel.
- Works with the leadership team to support hiring and staffing of the department.
- Monitors and manages functional contributions to programs to ensure commitments are satisfied.
- Works with management and senior R&D Hardware Engineering staff to define and implement design control processes that satisfy applicable regulatory requirements.
- Identifies developmental opportunities for engineering team members and mentors staff to advance their knowledge/skills with a heavy focus on GD&T and DFM.Networking/Key Relationships
- Research and Development
- Manufacturing Engineering
- Quality Engineering
- Product Management
- Executive leadership teamQualificationsMinimum Knowledge & Experience required for the position:
- Bachelor's degree required in Electrical, Mechanical or Chemical Engineering.
- Minimum of ten (10) years of previous experience required.
- Minimum of five (5) years of previous experience managing hardware engineering staff in the development and transfer of a complex medical device preferred.
- Must be familiar with Food and Drug Administration (FDA), Quality System Regulations (QSR), design control requirements, In-Vitro Diagnostic Medical Device Directive (IVDD), and ISO 9001.
- Excellent written and verbal communication skills are essential.
- Leadership abilities and interpersonal skills required.
- Knowledge of Microsoft Office and experience with large enterprise resource planning (ERP) system is essential.Skills & Capabilities:
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