Director, Systems Development

<p class=""p1"">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p>

Burlington, MA

Glaukos

<h4>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</h4> <h4>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</h4> https://www.glaukos.com/

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Full time

Overview: How will you make an impact? The Director, Systems Development will be a leadership role in Glaukos’ Research and Development department. This position will be responsible for the design and development of innovative, safe, and effective new products that will sustain Glaukos in a position of leadership within Ophthalmology. The Director, Systems Development will guide and manage programs and engineers to meet all internal and external requirements and play a critical role in the smooth and efficient running of the department, while producing a steady and prolific stream of product innovations, manufacturing improvements/efficiencies, and IP. In addition to these responsibilities, this person will manage personnel and projects and directly participate in the research, design, and development of medical devices. This role will lead electrical, mechanical, and optical engineers with a focus on meeting product specifications with technically strong, high-quality, cost-effective designs following Glaukos' defined development process. All duties shall be performed with attention to detail while supporting Glaukos Quality Policy and the appropriate regulatory agencies, including FDA Quality System Regulations (21 CFR 820) and ISO Standards (ISO 13485).
Responsibilities: Management:<ul><li>Responsible for keeping department programs on track and reporting status to</li><li>department head.</li><li>Establishes overall engineering project objectives.</li><li>Assigns technical tasks to subordinates and reassigns these tasks if priorities or resources change.</li><li>Develops and manages reporting and project management systems to efficiently track projects, resources, and timing.</li><li>Interfaces with the Software Engineering team, Operations, Applied Research, Quality Assurance, and Program management.</li><li>Helps engineers in accessing resources and support from other departments, decision making, reviewing/pursuing alternative/parallel courses of action, and all other typical means to ensure projects remain on track and meet all goals.</li><li>Monitors project development activities to ensure conformance to FDA Design Controls and Glaukos Standard Operating Procedures.</li><li>Determines short- and long-term capital, expense, and human resource requirements in their department, and creates strategic plans and roadmaps.</li><li>Fosters, reviews, and develops ideas for new products, product/process improvements, and cost reductions.</li><li>Creates and teaches Best Practices as needed to increase team efficiency in Product Development. Research & Development:</li><li>Participates as needed in the development of products/projects or certain aspects of projects where the department falls short of resources or needs expertise.</li><li>Ensures that projects are carried out to meet all program objectives, including manufacturability, cost, quality, capacity, robustness, design control, clinical safety, efficacy and ease of use, commercial value, and appeal.</li><li>Leads key strategic engineering projects and investigations. Documentation:</li><li>Ensures team compliance with the design control process inclusive of the Design History file and provides the technical strategy to complete a project, inclusive of authoring Design History File deliverables.</li><li>Supports regulatory filings by providing documentation of development activities.</li><li>Ensures that all necessary data is generated to permit successful and timely prototype release, regulatory submission, and subsequent approval where required as dictated by product launch schedule.</li><li>Oversees design control processes for assigned development projects, including conducting design reviews, writing and/or compiling all quality documentation including drawings, specs, DHRs, SOPs, meeting minutes, acting as a key participatory resource, and working closely with other Project Leaders, Product Development Engineers, Quality Assurance, Regulatory and Manufacturing.</li><li>Oversees the documentation and maintenance of risk analyses for all development products and complying with risk analysis, design control, and any other related procedures, working closely with project leader and other team members including CA/RA/QA, Manufacturing, etc. </li></ul>
Requirements: <ul><li>BS in Engineering with a preference for Electrical Engineering</li><li>12+ years of experience, 6+ years in medical device.</li><li>6+ years of managing direct report Engineers.</li><li>Proven track record of successfully leading NPD projects involving software, hardware, firmware, systems engineering, electrical, mechanical, and optical engineering.</li><li>Demonstrated experience setting a strategic vision and objectives for engineering teams</li><li>Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through to completion on time and on budget</li><li>Proven leadership in medical device research and development under Quality Systems that comply with ISO13485, MDR, and FDA Quality System Regulations</li><li>Familiar with safety requirements IEC60601-1, ANSI Z80.36, etc. </li></ul>