Senior Director, Design – Human Factors Engineering

Software EngineerSoftware EngineerFull TimeRemoteTeam 10,001+Since 1876H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

104 days ago

Salary

$163.5K - $264K / year

Postgraduate Degree10 yrs expEnglish

Job Description

• Lead and grow a top-tier engineering and science organization, which includes expertise in design and human factors engineering that is applied across the portfolio. • Ensures that: Human capabilities and limitations are adequately reflected in the system requirements • Human performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives • Human performance and safety risks are appropriately addressed in planning. • The staff is highly trained in Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance. • Human Factors Standards are appropriately documented in the Design Control Quality System. • Project milestones are met by identifying and managing risks and escalating as appropriate. • Functional budgets and project forecasts are maintained in compliance with P&L • Responsible for developing and managing the Design + Human Factors Engineering team. • Provides leadership, feedback, coaching, performance and career development support to direct reports. • Ensures career development discussions, talent assessment, and succession planning are in place for employees. • Builds and executes a comprehensive long-range recruiting strategy and technical succession plan to maintain a highly competitive cross-functional technical organization. • The Design & Human Factors Engineering Senior Director will be accountable for the execution of a Delivery and Device Strategy with other members of the management team.

Job Requirements

  • MS in Engineering with 10+ years or PhD in Engineering with 5+ years of delivery device design and development experience.
  • Experience with regulatory agencies interactions and/or regulatory submissions of delivery devices and combination products.
  • Experience working within a Sponsor organization
  • Working knowledge of HF regulatory requirements, protocols, IRBs, Usability studies and reporting.
  • Human subjects research bioethics and study design
  • Prior supervisory experience of team organization
  • Ability to work effectively across boundaries
  • Demonstrated quality mindset, ability to influence and leadership capabilities

Benefits

  • eligibility to participate in a company-sponsored 401(k)
  • pension
  • vacation benefits
  • eligibility for medical, dental, vision and prescription drug benefits
  • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • life insurance and death benefits
  • certain time off and leave of absence benefits
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

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