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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