Senior Manufacturing Engineer: Medical Device Labeling & NPI

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe. Position Summary The Senior Manufacturing Engineer is a hands-on position in the operations department which will perform duties as a sustaining and NPI manufacturing engineer as well as focus on packaging and labeling activities. This position reports to the Senior Manufacturing Engineering Manager. Responsibilities And Duties Collaborate closely with Production teams to provide sustaining engineering support, resolving product and process issues within a controlled cleanroom environment. Lead the development and lifecycle management of labeling content, including product labels, packaging labels, Instructions for Use (IFUs), inserts, and digital labeling. Ensure alignment with product design outputs and compliance with change control processes. Own the end-to-end labeling process—from concept development and artwork creation to print proofing, verification, and final release—utilizing tools such as ArtiosCAD, Adobe Illustrator, or equivalent platforms. Collaborate closely with Regulatory Affairs on packaging and labeling activities supporting regulatory submissions, product registrations, and global market expansion. Identify and drive production capacity improvements. Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites. Hands on development, qualification and implementation of new production systems integrating mechanics, electronics, and software. Identify, manage, and qualify alternate supply sources or new vendors. Hands on investigation and root cause analysis. Requirements Bachelor of Science degree in Engineering or related field with a minimum of 5 years in a regulated environment such as the medical device industry. 5 years of experience in global regulatory labeling and packaging requirements, including experience supporting new product introductions and implementing labeling updates across global markets. Proficiency with ERP systems and electronic label/UDI management tools Experience with disposable devices (Class II / III), preferably balloon catheters and sterile packaging. Strong collaboration skills with contract manufacturers and suppliers that include aligning goals, managing expectations, and ensuring adherence to specifications and timelines. Working knowledge of injection molded plastic components is a plus. Proficiency with statistical analysis tools (JMP, MiniTab). CAD experience (SolidWorks preferred). Self-motivated, action oriented and result oriented. Deep understanding of medical device processes and assembly knowledge to drive product yield and performance. Lean or Six Sigma experience (Green Belt a plus). Salary range : $138,375 - $145,000 (Commensurate with experience, skills, education and training) The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions. Equal Employment Opportunity At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Pre-Employment Requirement At Recor Medical, patient safety and compliance are at the heart of everything we do. To support these standards, employment for all field-based roles is contingent upon successfully completing a pre-employment background check and/or drug screen. These steps help ensure we bring the highest level of integrity and accountability to the physicians and patients we serve. Radiation Safety Requirement Certain field-based roles at Recor Medical require work in environments where radiation sources (e.g., x-ray equipment) are in use. Employees in these roles will be issued a personal dosimetry badge to monitor occupational exposure and are required to wear it in accordance with company policy and applicable regulatory standards. This program is designed to ensure compliance with federal and state regulations and to maintain radiation exposure at levels that are As Low As Reasonably Achievable (ALARA). Additional guidance and protective equipment, as necessary, will be provided as part of onboarding and ongoing safety training. Respecting your privacy is an essential part of the Company’s privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant’s application for employment, a Contract Worker’s work, or a Former Employee’s employment at Recor. Refer to our Applicant, Contract Worker & Former Employee Privacy Policy for more detail information. #J-18808-Ljbffr Recor Medical