Technical Documentation Specialist, Engineering ( {{...

About UsEngineered 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 CultureWe 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 OverviewThe 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 processKey ResponsibilitiesCreate and maintain design history files and other product-related documentationCreate and update process documentation (drawings, production instructions, etc.) associated with new productsCollaborate on the completion of product risk management documentationCollaborate within the Engineering Department and across multiple departments to ensure product and design-related documentation is completed and kept up to dateCreate and execute test protocols to ensure new products and enhancements to existing products are tested to ensure safety and effectivenessWrite reports for a variety of tests throughout research and development, including verification and validation testingUtilize a risk-based approach during the testing, analysis, and documentation of product development activitiesAssist with Identifying, specifying, and procuring lab equipment as requiredWork with Quality Assurance to develop quality control and testing specificationsCommunicate with project stakeholders as requiredConduct and/or participate in internal auditsCollaborate across multiple departments to create fixturing and displays as requiredWork in collaborative and independent work situations and environments with minimal supervisionQualifications & SkillsBachelor's degree in related field preferredBachelor's degree in Engineering/technical field OR 2-3 years related experience preferredAttention to detail and strong organizational skills for managing multiple projects concurrentlyAbility to collaborate in a team focused on design, development, and implementation of new processes required for the manufacture of new device designsExcellent problem-solving skillsStrong technical writing skills requiredProficiency in Microsoft Office products including Outlook, Excel, and WordBasic experience with SOLIDWORKS software preferredExperience with working in a medical device manufacturing environment preferredExperience with maintaining design and regulatory documentation for medical devices preferred, including device risk management and usability engineeringKnowledge of medical device quality standards (e.g. ISO 13485) / FDA practices, GMP, and similar regulated industry standards preferredExperience with writing and executing test protocols and reports preferredKnowledge of statistics and process validation principles preferredExcellent people skills preferred, including with internal and external stakeholdersRequirementsMust be able to speak, read, and write English fluentlyMust be able to sit, stand, and/or walk for extended periodsOccasionally required to lift up to 50 lbs. when handling returned orders or documentsWork EnvironmentTemperature-controlled facility with office and light manufacturing environmentNon-smoking environmentSafety hazards minimal with daily use of some chemicalsCompany-provided smock and hairnet mandatory in all controlled production areasClosed toe/heel shoes mandatory in all controlled production areasWe 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.BenefitsWe 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...

Created: 2025-09-23