Techlink Systems Inc

Job Title: Analyst, Product Surveillance II Location: Burlington, MA (onsite) Contract Duration: Contract until 01/08/2027 Work Hours: 8:00 - 5:00 PURPOSE OF THE ROLE Analyst, Product Surveillance II - (Sr Quality Specialist) Main Purpose of the Role: Conduct quality-related activities to deliver consistent, high-quality documents, services, products and processes. Ensure compliance with worldwide regulatory expectations/requirements. Top Skills/Experience Experience with complaint handling, medical writing and cross functional communication Regulatory knowledge and compliance expertise Data analysis skills with ability to use tools such as excel and Power BI Main Responsibilities Responsible for carrying out tasks related to core job responsibilities with little management oversight. May lead goals with cross-functional or broader scope. Provide solutions to a wide range of difficult problems. Solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. Responsible for demonstration of core competencies and may be measured against some selected leadership competencies in conjunction with growth and development plan. Identify and elevate areas for continuous improvement. May perform other duties as assigned. May provide oversight to one or more QA professionals and/or contractors. Scope limited to one specific QA function but has general knowledge of other related disciplines. Interacts with employees, manager, and cross-functional peers. May represent team on cross-functional project teams with other functional leaders. Implements tactical activities related to assignment. Able to contribute functional skills and expertise broadly. Directly influences project direction and scope. May lead projects within function. Decisions may have short- and long-term impact. Education Education Level Major/Field of Study or Equivalent Bachelor's Degree ( 5+ years) In life sciences or engineering. or An equivalent combination of education and work experience Experience Details Minimum 4 years In Quality or related field. Preferred Healthcare industry and experience in quality function. Utilize understanding of how their function supports the business and of technical/business competencies to drive continuous improvement results. Demonstrates proven track record utilizing core & technical competencies Developing product strategy with product management partners Shipped utilizing product control system Maintain software product management and agile product owner best practices Conduct product review with customer during product or process verification Solve business issues with software Effecting product development and launch Advise management on product development issues arising from product problems identified through technical support call with customers Develop new products or enhance existing product(s) or product Participate in pre-production testing and post-production support Reporting customer acceptance of product Consulting the customer product planning and analysis teams Analyze results of new product Help create detailed business requirements and technical system requirements Report for product file database analysis Performing routine inprocess testing to ensure product quality Conduct product review with customer during product or process verification Segregate and control non-conforming items Turn business needs into technical specifications that the software development team Perform product demonstrations to senior management Rotate and store all product

Job Title: Technical Writer - II Location: St. Paul, MN (hybrid) Contract Duration: 1 year Work Hours: 9:00AM - 5:00PM Technical Writer II and Software Requirements Analyst - Electrophysiology Overview We're seeking a hybrid Requirements Analyst & Technical Writer to support Electrophysiology's Research and Development system and software engineers to high quality technical documentation. You will collaborate with product managers, engineers, UX, QA, and other business stakeholders to refine and deliver requirement specifications and other software project deliverables-transforming complex technical concepts into concise, well-organized, and audience friendly documents. This role is ideal for someone who can think systematically, communicate precisely, and raise the bar on both clarity and delivery. Key Responsibilities Requirements Support & Analysis Support development of functional and non-functional requirements; provide change management of requirement documentation and a variety of software project deliverables. Facilitate technical review and workshop sessions with Systems and Software Systems engineers. Ensure requirements are well-written, feasible, testable, and aligned to ISO/IEC/IEEE 29148:2018 Maintain a single source of truth for requirements; manage baselines and versioning across releases. Assist in the development of tools such as glossaries, style guides, knowledge bases, data views, and workflows that support engineering business functions and data analysis. Edit and publish requirement specifications, software design and verification documentation for design control environments. Support creation and maintenance of requirements traceability matrices (RTMs) linking requirements to design, risk controls, and verification activities. Pilot and document workflows, requirement writing best practices, and guidance for larger team use and cross-functional alignment. Cross-Functional Collaboration Collaborate with Systems Engineering, Quality/Regulatory, Risk Management, and Software teams. Coordinate technical review meetings; moderating and recording action items and resolutions. Champion and support continuous improvement of requirements and documentation processes, tools, and metrics. Participate in backlog refinement, sprint planning, reviews, and grooming to clarify scope and acceptance criteria. Serve as a bridge between business, engineering, and QA-resolving ambiguity quickly and decisively. Qualifications Required Bachelor's degree in Technical Communication, Engineering, Computer Science, Biomedical Engineering, Systems Engineering, or relevant field; Clear understanding of software development processes (SDLC). Excellent communication and documentation skills. Willing to learn medical device regulations and quality processes. Demonstrated ability to work proactively and independently. Experience with requirements tools: DOORS, Codebeamer, JAMA Experience with the software development process and deliverables. Experience with SharePoint, Confluence, JIRA Advanced skills in MS Office suite: Word, Excel, Powerpoint, Visio Key Competencies Service-oriented mindset Curiosity and willingness to learn Attention to detail Critical and analytical thinking Ability to understand and summarize advanced technical concepts Excellent organizational skills Strong content management Comparing software purchased to software Support the software quality effort on software projects Evaluate proposed software or software enhancement for feasibility Support high level software product testing Design, implement and test software applications Develop, modify and execute software testing plans for assigned software Assist with software license tracking and renewals for software maintenance Managing software and hardware inventory Optimize the software asset portfolio Enable software licensing lifecycle management from procurement to retirement of software Maintain test cases and test data Validate requirements for multiple software and hardware products throughout the software life cycle Perform analysis and reporting of software installations and optimize software licenses Perform software inventory management tasks Improve software testing in an ever changing environment Execute the software development plans to perform requirements analysis, software design, coding, unit test, and integration testing Assist planning and leading the development of system requirements, software design, coding, software/system analysis, process, software verification, documentation and testing Modify and execute software test plans Participate in various reviews of test artifacts such as test plans, test cases and test scripts Create and update software counters for software titles and licenses