> Markdown version of [/jobs/ext/135727-senior-design-quality-engineer](https://www.wearedevelopers.com/jobs/ext/135727-senior-design-quality-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Design Quality Engineer - **Company:** Impulse Dynamics - **Location:** Evesham, NJ, United States - **Experience:** Expert - **Salary:** $120,000.0 - $130,000.0 - **Contract:** Permanent contract - **Skills:** Microsoft Word, Microsoft Excel, Productivity Software, Technical Data Management Systems, Mdsap - **Published:** May 22, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=d371e6cb230b56fd ## About the Role Do you have experience in Productivity software?, * BS in Engineering or Life Science Field * 10 years of experience in medical device industry or regulated environment (e.g., ISO 13485:2016, 21 CFR Part 820 and MDSAP) in one of the following functions: Quality Assurance/Quality Engineering or Product Development Engineering * Educational/work background that includes work with medical instrumentation is required. * Work experience in the Medical Device Industry, Defense Industry or the Armed Forces in highly desirable. * Strong communication and organizational skills. * Intermediate to advanced knowledge of MS Office Suite (e.g., Word, Excel) * Self-starter with high attention to detail and ability to work on multiple projects * Demonstrated ability to participate in cross-functional team environment * Strong written and verbal communication skills * Ability to work independently with little to no supervision * Excellent organizational abilities and superior attention to detail * Must have high level of interpersonal skills * Possesses strong analytical and problem-solving skills * Excellent time management skills and project management skills * Capability of objective analysis * Proactive attitude to address problems ## Description There are 64 million patients struggling with Heart Failure worldwide. When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope. The only options down the road are extremely invasive. CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. This is not a job, It is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy. The Sr QE is Responsible for providing QA leadership and partnering with product development with planning, coordinating, and managing the quality assurance (QA) activities associated with PD projects to ensure compliance to internal and external requirements during the development and commercialization of new products and changes for existing products. Responsible for providing technical leadership in establishing, implementing, and maintaining quality system processes and documentation in compliance with domestic and international regulatory/quality requirements How You'll Add Value * Design Control expert who: works with product development engineering to ensure proper completion of required documentation for design control phases according to the design controls SOP. * Quality lead on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards. * Assure that all applicable elements and product technical standards that are applicable to a design category are effectively incorporated into new designs and into changes to designs * Complete Risk Management activities for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required * Author and maintain all risk documentation required for Impulse Dynamics products * Complete and own design history file verifications during and at the end of each design control phase. * Review and approve all external Engineering Change Orders provided by the contract manufacturer and assesses risk documentation. * Assist in writing, updating and/or reviewing of procedures and other quality assurance related technical data forms and quality documents. * Adhere to QMS requirements outlined in procedures and work instructions. * Review validation protocols and reports for GMP compliance * Assist in carrying out internal quality audits on company systems and documentation * Authors non-conformance reports and corrective actions * Perform investigations of non-conformances, customer complaints and corrective actions * Ensures the timely and effective follow-up of all identified or assigned quality issues * Assists in the maintenance of the Quality Management System * Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices * Provide training and support for quality system processes and quality engineering practices * Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies to include but not limited to ISO 13485:2016, 21 CFR part 820, 21 CFR part 812, MDSAP and MDR * Develop, conduct, and document Quality design engineering procedures, including equipment repair, failure analysis, and product deployment. * Write clear and detailed technical reports and procedures in English. ## Related Videos - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [In-depth .NET Azure Functions: Isolated mode, performance and durable AI agents](https://www.wearedevelopers.com/videos/100207-in-depth-net-azure-functions-isolated-mode-performance-and-durable-ai-agents) - [Developing the Rich Text Editor for DeepL.com](https://www.wearedevelopers.com/videos/1172-developing-the-rich-text-editor-for-deepl-com) - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) - [From Syntax to Singularity: AI’s Impact on Developer Roles](https://www.wearedevelopers.com/videos/900-from-syntax-to-singularity-ai-s-impact-on-developer-roles) - [What If We Designed Employee Experience Like a Customer Journey?](https://www.wearedevelopers.com/videos/1824-what-if-we-designed-employee-experience-like-a-customer-journey) ## Related Articles - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [Events like RSAC Get You CISOs. Developers Decide What Actually Gets Deployed.](https://www.wearedevelopers.com/magazine/693-events-like-rsac-get-you-cisos-developers-decide-what-actually-gets-deployed) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer)