Senior Medical Device Product Safety Engineer

CSA Group Testing & Certification Inc.; Irvine (CA); On-site; USD 100,000 - 160,000; Full time

Job summary

CSA Group, a standards development and product certification organization, is seeking an experienced Product Safety Engineer, Medical Devices in Irvine, CA. The role focuses on safety certification of new and leading-edge medical equipment to meet Essential Performance standards.

You will manage multiple certification projects, review data and reports, and collaborate with lab staff to ensure compliance, on-time delivery and adherence to CSA/UL/IEC standards across diverse healthcare

Qualifications

• Bachelor's Degree in Engineering or related field.
• Experience with medical device standards and certification processes.
• Ability to read, interpret and develop engineering drawings.

Responsibilities

• Independently manage certification projects concurrently ensuring compliance with all applicable safety requirements achieving completion within time frames and cost deadlines.
• Evaluate products against requirements of the national / international standards and precedent decisions.
• Demonstrate technical competency to review the work of others.
• Demonstrate technical competency in their respective certification programs.
• Able to accurately perform evaluation and review of complex, unique or unusual product types.
• Demonstrates the ability to consistently manage multiple projects concurrently while maintaining on-time and on-budget performance.
• Reviews test data, reports and authorizes application of Certification Marks. Prepares and / or signs Certification Reports and Certificates of Compliance.
• Conduct construction evaluation, ensuring the unit complies with the construction section of the standard; identifies rationale for compliance or non-compliance.
• Collaborate with Lab Technician to create a work order which test are required and; the order of the tests and the number of samples required.]
• ],
• CoT_job_summary_short
• COMPANY NAME: CSA Group Testing & Certification Inc.KEY POINTS: Certification project management, risk-based safety standards, medical device certification
• job_summary_short
• <p>CSA Group, a standards development and product certification organization, is seeking an experienced Product Safety Engineer, Medical Devices in Irvine, CA. The role focuses on safety certification of new and leading-edge medical equipment to meet Essential Performance standards.</p><p>You will manage multiple certification projects, review data and reports, and collaborate with lab staff to ensure compliance, on-time delivery and adherence to CSA/UL/IEC standards across diverse healthcare environments.</p><p>Candidates should have an engineering degree and extensive experience with medical device standards; the position offers growth potential and a structured environment.</p>
• contract_type
• fulltime
• location_type
• on site
• remote_scope
• perks
• []
• stated_min
• null
• stated_max
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• stated_absolute
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• salary_estimation_cot
• Product Safety Engineer, Medical Devices in Irvine, CA: market range roughly $100k–$160k per year based on experience and regulatory scope.
• estimated_low
• 100000
• estimated_medium
• 135000
• estimated_high
• 160000
• currency
• USD
• frequency
• yearly
• bonus
• null
• tax
• gross
• application_email
• null
• job_end_date
• null
• contact_person
• null
• hiring_department_name
• null
• company_name
• CSA Group Testing & Certification Inc.

Skills

Interpersonal skills

Communication skills

Customer service

Time management

Organizational skills

Project management

Engineering drawings

Teamwork

Engineering standards knowledge

Education

Bachelor's Degree in Engineering

Engineering Technology degree

Tools

Microsoft Office

Lab equipment

Job description

CSA Group, a standards development and product certification organization, is seeking an experienced Product Safety Engineer, Medical Devices in Irvine, CA. The role focuses on safety certification of new and leading-edge medical equipment to meet Essential Performance standards.

You will manage multiple certification projects, review data and reports, and collaborate with lab staff to ensure compliance, on-time delivery and adherence to CSA/UL/IEC standards across diverse healthcare