Safety Engineer

Elekta; United States; Hybrid; USD 79,000 - 126,000; Full time

Benefits offered by this job

Up to 25 paid vacation days (plus bank

Holiday Purchase Scheme

Private Medical Insurance

Employer Pension Contribution

Cycle to work scheme

Life Assurance

Onsite subsidized restaurant

Electric vehicle salary sacrifice

Job summary

Elekta is seeking a risk management professional in Crawley to support regulatory compliance and product safety throughout the lifecycle of medical devices. You will collaborate with engineering, QA, and product teams to integrate risk assessment into design decisions and post-market monitoring.

The role emphasizes adherence to ISO 14971 and relevant IEC standards, with a focus on delivering clear risk-based recommendations for product releases.

Qualifications

• Degree in Engineering, Life Sciences or related field.
• Experience in product safety, risk management, or regulated industries.
• Understanding of risk management principles across product lifecycle.

Responsibilities

• Document risk management activities and provide recommendations for product release decisions.
• Ensure products and processes meet regulatory and risk management requirements.
• Collaborate with cross-functional teams to embed safety and risk awareness into design and development.
• Prepare and maintain risk management reports and post-market reviews.

Skills

Risk management

Cross-functional collaboration

Regulatory compliance

Education

Engineering degree

Life sciences degree

Tools

ISO 14971

IEC 60601-1

IEC 61508

IEC 62304

Job description

13485, ISO 14971, IEC 60601, IEC 61508, IEC 62304, FDA, NMPA, and MDR requirements. Strong communication and collaboration skills, with the ability to work effectively across a range of teams and stakeholders.

What You’ll Get:

In this role, you will work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care.

In addition to this, Elekta offers a range of benefits.

• Up to 25 paid vacation days (plus bank holidays)
• Holiday Purchase Scheme
• Private Medical Insurance
• Attractive Employer Pension Contribution Package
• Cycle to work scheme
• Life Assurance
• Onsite subsidized restaurant, offering budget-friendly dining
• Love electric (Electric vehicle salary sacrifice scheme)

Work Pattern (you are required to work from the Crawley HQ 4 days a week with 1-day WFH)

Summary

Location: Crawley

Type: Full time

Responsibilities

• document risk management activities, providing clear recommendations to support product release decisions.
• Ensure products and processes meet relevant regulatory and risk management requirements.
• Work collaboratively with cross-functional teams to embed safety and risk awareness into product design and development.
• Prepare and maintain key risk management reports and monitoring activities, including post-market reviews and ongoing product assessments.

What You’ll Bring:

• A degree in Engineering, Life Sciences, or a related discipline, or equivalent practical experience.
• Experience in product safety, risk management, or a related discipline within the medical device or other regulated industries.
• A good understanding of risk management principles and how they are applied throughout the product lifecycle.
• Knowledge of medical device regulations and the requirements of working in a highly regulated environment.
• Experience, interpreting and applying relevant standards and regulations, including ISO

We are an equal opportunity employerWe are an equal opportunity employer. We evaluate qualified applicants without regard to age, race, colour, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.

We don't just build technology. We build hope for everyone dealing with Cancer.Elekta is shaping the standard of care, together with healthcare providers, by developing precision radiation medicine that brings advanced radiotherapy into routine clinical practice. Our solutions support consistent, efficient and personalized care, addressing evolving patient needs. Through adaptive radiotherapy, precision treatment delivery and integrated workflows, Elekta supports care teams across a range of clinical settings. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com.We don't just build technology. We build hope for everyone dealing with