Instrumentation Laboratory - San Diego, CA

posted 13 days ago

Full-time - Senior
San Diego, CA
Miscellaneous Manufacturing

About the position

The Senior Hardware Engineering Manager is responsible for leading a team of mechanical and process engineers in product development activities. This role involves cross-functional collaboration to establish plans and budgets for the department, ensuring high-quality deliverables, and managing new product development projects from design transfer to market activities.

Responsibilities

  • Establish requirements, plan features, define engineering tasks, provide engineering estimates, and develop schedules for projects.
  • Ensure the team creates high-quality deliverables such as design documentation, process documentation, and product release documentation.
  • Participate in design reviews and manage new product development projects through design transfer and on-market activities.
  • Work with leadership and cross-functional stakeholders to prioritize, plan, and distribute workload to engineering personnel.
  • Support hiring and staffing of the department in collaboration with the leadership team.
  • Monitor and manage functional contributions to programs to ensure commitments are satisfied.
  • Define and implement design control processes that satisfy applicable regulatory requirements in collaboration with management and senior R&D Hardware Engineering staff.
  • Identify developmental opportunities for engineering team members and mentor staff to advance their knowledge and skills.

Requirements

  • Bachelor's degree in Electrical, Mechanical, or Chemical Engineering.
  • Minimum of ten (10) years of previous experience in hardware engineering.
  • Minimum of five (5) years of experience managing hardware engineering staff in the development and transfer of complex medical devices.
  • Familiarity with FDA, QSR, design control requirements, IVDD, and ISO 9001.
  • Excellent written and verbal communication skills.
  • Strong leadership abilities and interpersonal skills.
  • Knowledge of Microsoft Office and experience with large ERP systems.

Nice-to-haves

  • Experience in product reliability and budgeting.
  • Mechanical engineering expertise.
  • Strong interpersonal communication and presentation skills.

Benefits

  • Competitive salary range of $185,000 - $210,000 based on experience and skills.
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