[Remote] Design + Human Factors Engineering Senior Director at Eli Lilly and Company

Chester, Maryland, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, PharmaceuticalsIndustries

Requirements

Expertise in design and human factors engineering applied across medical device, combination product, and packaging programs
Deep knowledge of Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75), and FDA guidance
Ability to reflect human capabilities, limitations, performance characteristics, costs, benefits, and risks in system requirements and decision-making
Experience in Design Control Quality Systems for documenting Human Factors Standards
Skills in risk identification, management, escalation, project milestone achievement, and budget/forecast compliance with P&L
Leadership experience in developing, managing, coaching, and providing performance/career development support to engineering/science teams
Capability to conduct career development discussions, talent assessment, and succession planning
Proficiency in building and executing long-range recruiting strategies and technical succession plans
Strategic planning skills for Delivery and Device Strategy execution in collaboration with management teams

Responsibilities

Lead and grow a top-tier engineering and science organization with expertise in design and human factors engineering across the portfolio
Ensure human capabilities and limitations are reflected in system requirements
Ensure human performance characteristics, costs, benefits, and risks inform decision-making among alternatives
Ensure human performance and safety risks are addressed in planning
Ensure staff is highly trained in Human Factors processes, standards (IEC 62366, ANSI/AAMI HE75), and FDA guidance
Ensure Human Factors Standards are documented in the Design Control Quality System
Meet project milestones by identifying/managing risks and escalating as appropriate
Maintain functional budgets and project forecasts in compliance with P&L
Develop and manage the Design + Human Factors Engineering team, providing leadership, feedback, coaching, performance, and career development support
Ensure career development discussions, talent assessment, and succession planning for employees
Build and execute comprehensive long-range recruiting strategy and technical succession plan
Provide strategic direction, execution, and reporting of design and human factors activities across all programs per regulations and guidelines
Execute Delivery and Device Strategy with management team in response to business growth

Skills

Key technologies and capabilities for this role

Design EngineeringHuman Factors EngineeringProduct InnovationProduct DevelopmentDelivery SystemsDevice SystemsStrategic LeadershipRegulatory Compliance

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require working from a specific location?

This information is not specified in the job description.

What are the key responsibilities of this role?

The role involves leading and growing a top-tier engineering and science organization with expertise in design and human factors engineering applied across the portfolio, ensuring human capabilities are reflected in system requirements, and addressing human performance and safety risks.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, and focuses on patient-centered solutions with an innovative approach utilizing internal and external technologies.

What makes a strong candidate for this Senior Director role?

A strong candidate should have expertise in leading design and human factors engineering teams, deep knowledge of standards like IEC 62366, ANSI/AAMI HE75, and FDA guidance, and the ability to provide strategic direction for medical device and combination product programs.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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