Technical Documentation Specialist, Engineering - Intersurgical, Inc. USA : Job Details

About Us

Engineered Medical Systems, an Intersurgical Inc. company, is a global leader in the fields of anesthesia, respiratory care and medical device manufacturing. We partner with providers, manufacturers and other organizations to supply innovative airway and medical devices that impact the lives of patients every day. Driven by our commitment to supply high quality medical devices, our team works to deliver best in class products to over 60 countries worldwide.

Our Culture

We celebrate our culture of collaboration and communication. We believe in a workplace where everyone can be their full, authentic selves. We welcome and encourage those with diverse perspectives, veterans, and individuals with disabilities to join our team. We are an ambitious and innovative company and look forward to the unique experiences and different points of view you'll bring to the table while fostering a spirit of communication.

Job Overview

The Technical Documentation Specialist plays a key role in creating and maintaining product design & development and related documentation, as well as organizing and executing testing required as part of the product development process

Key Responsibilities

• Create and maintain design history files and other product-related documentation
• Create and update process documentation (drawings, production instructions, etc.) associated with new products
• Collaborate on the completion of product risk management documentation
• Collaborate within the Engineering Department and across multiple departments to ensure product and design-related documentation is completed and kept up to date
• Create and execute test protocols to ensure new products and enhancements to existing products are tested to ensure safety and effectiveness
• Write reports for a variety of tests throughout research and development, including verification and validation testing
• Utilize a risk-based approach during the testing, analysis, and documentation of product development activities
• Assist with Identifying, specifying, and procuring lab equipment as required
• Work with Quality Assurance to develop quality control and testing specifications
• Communicate with project stakeholders as required
• Conduct and/or participate in internal audits
• Collaborate across multiple departments to create fixturing and displays as required
• Work in collaborative and independent work situations and environments with minimal supervision

Qualifications & Skills

• Bachelor's degree in related field preferred
• Bachelor's degree in Engineering/technical field OR 2-3 years related experience preferred
• Attention to detail and strong organizational skills for managing multiple projects concurrently
• Ability to collaborate in a team focused on design, development, and implementation of new processes required for the manufacture of new device designs
• Excellent problem-solving skills
• Strong technical writing skills required
• Proficiency in Microsoft Office products including Outlook, Excel, and Word
• Basic experience with SOLIDWORKS software preferred
• Experience with working in a medical device manufacturing environment preferred
• Experience with maintaining design and regulatory documentation for medical devices preferred, including device risk management and usability engineering
• Knowledge of medical device quality standards (e.g. ISO 13485) / FDA practices, GMP, and similar regulated industry standards preferred
• Experience with writing and executing test protocols and reports preferred
• Knowledge of statistics and process validation principles preferred
• Excellent people skills preferred, including with internal and external stakeholders

Requirements

• Must be able to speak, read, and write English fluently
• Must be able to sit, stand, and/or walk for extended periods
• Occasionally required to lift up to 50 lbs. when handling returned orders or documents

Work Environment

• Temperature-controlled facility with office and light manufacturing environment
• Non-smoking environment
• Safety hazards minimal with daily use of some chemicals
• Company-provided smock and hairnet mandatory in all controlled production areas
• Closed toe/heel shoes mandatory in all controlled production areas

We are an Equal Opportunity Employer that takes pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.

Benefits

We are passionate about the well-being of others and that begins with caring for our people.

• 💰 Competitive salary
• 🧠 Multiple opportunities to be challenged and step up your career in a fast-growth company
• 📈 401k
• 🏖️ Paid Time Off and holidays
• 😌 Medical, dental, and vision benefits
• 👀 Much more...