Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We are building on our rich history, and believe our greatest achievements are ahead of us. We invite you to apply and join us if you're passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization. Experience and contribute to our unique culture while you develop and expand your career! SENIOR RESEARCH ASSOCIATE, PHARMACEUTICAL DEVELOPMENT SUMMARY: We are seeking a dynamic individual to join the medical device team within the pharmaceutical development group. This role focuses on developing drug delivery devices / combination products and bringing them through regulatory approval to the commercial market. Day to day tasks are often broad with multiple projects in various stages of development concurrently. This position will contribute to all phases of development from early concept to transfer to manufacturing. RESPONSIBILITIES: * Manage multiple design history files for several drug-device combination products * Author design input/requirements and design output/specifications documents * Create design verification plans and manage testing across multiple vendors * Contribute to test method development and test method validation * Conduct internal feasibility studies on early stage concepts * Support authoring of regulatory submissions * Work with supply chain and external CMOs to develop manufacturing processes * Assist with packaging and labeling development and testing REQUIREMENTS: * BS in engineering or related field, additional education a plus * At least 5 years of experience exhibiting strong mechanical fundamentals knowledge * Strong understanding of design controls and stage gate process * Experience developing and/or commercializing medical devices * Familiarity with FDA 21 CFR Part 820 Design Controls and/or Part 4 Combination Products * Experience working within a quality system under regulatory oversight with GDP * Systems engineering experience and managing product requirements * Design verification and design validation experience * Experience with human factors a plus * Early stage development of novel products a plus * Prototyping / CAD skills a plus Please visit our website, http://www.ionis.com, for more information about Ionis and to apply for this position; reference requisition #IONIS003497 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=to%20Applicants%C2%A0%C2%BB-,Benefits,-Employees%20are%20rewarded The pay scale for this position is $98,269 to $131,840 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.