Associate Director Engineering

BioSpace; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Comprehensive employee benefits package

Retirement and savings plan

Generous PTO and flexible work models

Job summary

A leading biotech company in California is seeking an Associate Director for Engineering to lead human factors and usability engineering initiatives. The role demands strategic leadership to integrate user-centered principles in product development, ensuring interactions are safe and effective for patients and healthcare professionals. Candidates must hold advanced degrees with significant experience in human factors and must demonstrate strong leadership capabilities. The opportunity offers competitive compensation and a collaborative working environment.

Qualifications

• Doctorate degree with 3 years experience, or equivalent qualifications with more experience.
• Minimum 3 years experience directly managing people or teams.
• Experience leading teams in human factors or usability.

Responsibilities

• Lead and mentor the human factors and usability engineering team.
• Build scalable processes and tools for human factors integration.
• Define HF/UE strategy aligned with regulatory requirements.
• Define and drive HF/UE strategy aligned with regulatory requirements and milestones.
• Oversee planning and execution of formative and summative human factors studies per FDA, EMA, MDR, ISO 62366, and global standards.
• Ensure seamless HF/UE integration within design controls and ISO 14971 risk management.
• Author and review HF/UE documentation including plans, risk analyses, validation protocols, reports, and regulatory responses.
• Integrate use‑related risk management across the product lifecycle to minimize on‑market risk.
• Collaborate cross‑functionally with Device Engineering, Regulatory Affairs, Quality, Medical, Packaging, Manufacturing, and Operations teams.
• Provide HF leadership in feasibility assessments and early‑stage design decisions.

Skills

Leadership

Human Factors Engineering

Regulatory Knowledge

Usability Testing

Education

Doctorate degree or equivalent experience

Master's degree or equivalent experience

Bachelor's degree or equivalent experience

Associate's degree or equivalent experience

High school diploma / GED or equivalent experience

Job description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas oncology, inflammation, general medicine, and rare disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Associate Director – Engineering

We are looking for an Associate Director, Human Factors & Usability Engineering (HF/UE) to provide strategic and operational leadership for integrating human factors, usability, and user‑centered risk management across Amgen's product portfolio. This role ensures that human factors and usability principles are embedded throughout the product lifecycle from early concept development through post‑market surveillance to deliver safe, effective, and intuitive products for patients, caregivers, and healthcare professionals.

What You Will Do

Let's do this! Let's change the world!

Key Responsibilities

• Lead, develop, and mentor a high‑performing human factors and usability engineering team.
• Build enterprise capability in human factors and usability by establishing scalable processes, tools, and best practices.
• Champion the integration of human factors, usability, and user‑centered design into product development processes.
• Define and drive HF/UE strategy aligned with regulatory requirements, development milestones, and quality systems.
• Oversee planning and execution of formative and summative human factors studies in alignment with FDA, EMA, MDR, ISO 62366, and global standards.
• Ensure seamless integration of HF/UE activities within design controls and risk management (ISO 14971).
• Author and review HF/UE documentation including plans, use‑related risk analyses, validation protocols, reports, and regulatory responses.
• Integrate use‑related risk management across the product lifecycle to minimize on‑market risk.
• Collaborate cross‑functionally with Device Engineering, Regulatory Affairs, Quality, Medical, Packaging, Manufacturing, and Operations teams.
• Provide HF leadership in feasibility assessments and early‑stage design decisions.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications

• Doctorate degree and 3 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience, OR
• Master's degree and 7 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience, OR
• Bachelor's degree and 9 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience, OR
• Associate's degree and 12 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience, OR
• High school diploma / GED and 14 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience.

In addition to meeting at least one of the above requirements, you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications

• Advanced degree in Human Factors Engineering, Industrial Design, Psychology, Biomedical Engineering, or related discipline.
• Experience in medical devices, combination products, or regulated healthcare environments.
• Deep knowledge of FDA human factors guidance, ISO 62366, ISO 14971, MDR, and design controls.
• Proven experience leading formative and summative studies supporting regulatory submissions.
• Expertise integrating human factors and usability engineering with risk management and quality systems.
• Strong communication skills, including regulatory documentation and executive presentations.
• Experience managing external research vendors and usability testing partners.

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we support your journey every step of the way.

Compensation and Benefits

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a total rewards plan, composed of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities. This may include:

• A comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Application Deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

Equal Opportunity Employer

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

careers.amgen.com