Senior Manager, Hardward Engineering

Posted 19 November 2024
Salary 160,000-180,000
LocationSan Diego
Job type Permanent
Discipline Engineering & CQV
Reference207343
Contact NameMelody Lam

Job description

The 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.

Responsibilities
  • 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.)
  • Participates in design reviews.
  • Manages through 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. Heavy focus on GD&T and DFM.

Qualifications
  • 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.