Technical Writer

Description

We are seeking a dedicated Technical Writer to join our team. The ideal candidate will be responsible for ensuring that our medical devices testing activities are properly documented to meet all regulatory standards and perform as expected. This role emphasizes thorough documentation of all validation and verification testing activities. Key Responsibilities:• Work closely with Test Engineers and internal cross functional team to support new product development activities • Develop validation and verification protocols, final reports, and activities • Create design documentation and update validation and verification test plans and test scripts for new and existing medical devices. • Document potential product failures and devise strategies to minimize risks. • Generate required product development documentation including functional specifications and test reports • Ensure all documentation complies with domestic and international regulatory standards, including FDA, ISO 13485, Iso 1497, IEC standards, and EU MDR. • Prepare comprehensive reports detailing validation and validation activities and results. • Work with design, manufacturing, and quality assurance teams to implement improvements and correct defects. • Involved in cross functionals activities using root cause analysis, risk assessment, CAPA, incident reports, change control and deviation reports • Provide technical Support to team members on validation processes and procedures. • Keep abreast of emerging trends, technologies, and regulations in medical device production.

Skills

Report writing, technical writing, test report writing, test report documention

Additional Skills & Qualifications

Qualifications: • Bachelor's degree in engineering or a related field required • Minimum of 3-5 years of experience documentation test activities within the medical device industry. • Understanding of regulatory standards, excellent documentation skills, and proficiency in risk assessment and root cause analysis. Preferred Attributes: • Detail-oriented with strong analytical skills. • Excellent communication and teamwork abilities. • Ability to manage multiple projects and meet deadlines.

Experience Level

Intermediate Level

Pay and Benefits

The pay range for this position is $35.00 - $50.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Richardson,TX.

Application Deadline

This position is anticipated to close on Feb 24, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.