Search for Technical Writer roles in Pittsburgh, specifically in the medical device industry, requiring 3+ years of experience, with knowledge of global medical device regulations, and a bachelor's degree in Engineering.

Okay, I've searched for Technical Writer roles in Pittsburgh within the medical device industry, requiring 3+ years of experience, a bachelor's degree in Engineering, and knowledge of global medical device regulations. I have found 27 positions for you.

Technical Writer

Pittsburgh, PA

Medical Devices

3 years + Experience

Bachelor

Can you help me to analyze the job description and company culture?

Sure. Here's the analysis:

Job Analysis:

The Technical Writer - Medical Devices at Tanisha Systems is fundamentally responsible for creating clear, comprehensive documentation that aligns with the regulatory standards of the medical device industry. This includes drafting and updating Standard Operating Procedures (SOPs) and Quality Management System (QMS) documents while maintaining compliance with rigorous industry regulations such as 21 CFR Parts 803, 806, and 820, and ISO 13485. The role requires coordination between cross-functional teams to define necessary procedural updates and train staff on new protocols, highlighting the importance of communication and attention to detail. Candidates will frequently encounter challenges such as managing change requests, improving efficiency in documentation processes, and ensuring compliance in a fast-paced environment. Success in this role would be visible through timely document releases, effective training sessions, and the ability to manage feedback loops for continuous improvement while building a culture of quality across teams.

Company Analysis:

Tanisha Systems, established in 2002, operates in the lucrative and high-stakes domain of Custom Application Development and IT Services, specifically catering to clients in the medical device industry. As a provider that utilizes a client-centric model blending on-site and off-shore resources, the company emphasizes tailored solutions that help clients achieve their critical business objectives. The organizational mission reflects a commitment to enhancing productivity and client satisfaction, which is vital in the highly regulated medical device sector. The company culture likely prioritizes collaboration, attention to quality, and continuous improvement, fostering an environment where technical writers must align well with both compliance requirements and client expectations. Given the structured yet agile nature of the business, new hires, like the Technical Writer, will likely be expected to adapt swiftly while maintaining rigorous documentation standards. The role serves an essential purpose in upholding Tanisha's vision of establishing long-term, strategic relationships with clients by ensuring their products meet the highest quality standards and regulatory compliance.

Mock up some interview questions based on the job description.

Absolutely. Here are some mock interview questions that could come up:

Describe a time when you had to develop technical documentation under a tight deadline. What approach did you take?
Can you share an experience where you improved an existing document or process? What was the result?
Tell me about a challenging technical concept you've had to explain in writing. How did you ensure your audience understood?
How do you prioritize tasks when managing multiple documentation projects simultaneously?
What steps do you take to ensure that your documentation complies with regulations specific to the medical device industry?
How would you go about updating a Standard Operating Procedure for a device that has undergone significant changes?
What tools or methods do you use to gather feedback from cross-functional teams on technical documents?
Imagine a scenario where the feedback to your technical documentation is largely negative. How would you handle that situation?
If a compliance issue arose due to a documentation error, how would you approach resolving both the error and its impact?
What interests you most about working with Tanisha Systems in the medical device field?
How do you align your work as a Technical Writer with the company’s mission to deliver exceptional client outcomes?
What is your understanding of CAPA processes, and how would you incorporate them into your technical writing?
Could you tell us about your experience with CAD and Visio and how those tools contribute to your documentation process?
What are some challenges you anticipate in this Technical Writer role, and how would you prepare to overcome them?
What strategies do you employ to ensure great attention to detail in your writing process?
What would you like to know about the collaborative processes at Tanisha Systems that support technical writing?

Job Details

Overview Company

Technical Writer

Tanisha Systems, Inc

17 hours ago

Highlight

OnsiteFull-time3+ yearsMid

Summary

Tanisha Systems, Inc is seeking a Technical Writer - Medical Devices to join their team in Pittsburgh, PA. The role involves creating and updating technical documentation for medical devices, ensuring compliance with industry standards.

About the Role

As a Technical Writer - Medical Devices, you will be responsible for maintaining and updating the client's QMS design controls procedures, coordinating with cross-functional teams, and planning training roll-outs. You will also gather feedback from project teams and ensure procedural updates are aligned across functions.

About You

Required:

Bachelor’s degree, preferably in Engineering.
2+ years of experience as a Technical Writer in the medical device industry.
Practical knowledge of medical device industry standards and regulations.
Experience with CAD and Visio.
Good communication skills and attention to detail.

Preferred:

3+ years writing effective Medical and Technical narratives.
Experience in design quality assurance in medical devices.
Understanding of CAPA and global medical device regulations such as 21 CFR Parts 803, 806, and 820, and ISO13485.

Tanisha Systems, Inc

Tanisha Systems, founded in 2002 in Massachusetts-USA, is a leading provider of Custom Application Development and end-to-end IT Services to clients globally. We use a client-centric engagement model that combines local on-site and off-site resources with the cost, global expertise and quality advantages of off-shore operations. We deliver Custom Application Development, Application Modernization, Business Process Outsourcing and Professional IT Services from office locations in USA and India.

Mission

To develop Outsource and Co-source Turnkey Projects for Government and Industries around the globe and yield higher productivity, higher profitability and higher satisfaction for our clients. Help clients to achieve critical business objectives. Setting new standard in IT Project Delivery & Service. Transforming lives by collaborating with clients.

Vision

Our vision is to accelerate execution of our growth strategy while continuing to build our brand with clients, community and our employees. In every business engagement, we seek the opportunity to build long-lasting, strategic relationships with our client-centric focus that forms the basis for how we, as a company, operate and serve our clients. To be the best global IT delivery company, delivering solution by combining our unparalleled experience and capabilities across all industries, and collaborating with clients.

Pittsburgh, PA