Position Summary We are seeking a Combination Product Manager, R&D to support the development of drug-device combination products. This role is responsible for managing product design, risk management, and regulatory documentation. The position will work closely with internal teams and external partners to ensure products are safe, effective, and compliant.Reporting Structure This role reports to the Executive Director, External R&D and works with Quality, Regulatory, Clinical, Supply Chain, and external design firms, manufacturers, and suppliers. Key Responsibilities Support the design and development of drug-device combination products using design control processes Prepare, review, and maintain Design History Files (DHF) and risk management documentation Work with external partners to review product designs and development progress Provide technical support for combination products such as injectors, inhalers, transdermal systems, and infusion devices Ensure documentation meets regulatory and quality requirements Support product risk assessments, complaint investigations, and product improvements Partner with Quality and other teams to maintain compliant product files Stay current with regulatory requirements and industry standards Qualifications BS or MS in Mechanical Engineering, Chemical Engineering, or related field 5–7 years of experience developing drug-device combination products Experience with design controls and risk management Experience with Design History Files (DHF) preferred Strong communication and technical writing skills Ability to work independently and work with cross-functional teams

Responsibilities: Support product release activities in compliance with FDA QSR and ISO 13485Author, execute, and review validation documentation (IQ/OQ/PQ, process and packaging validations)Prepare and maintain controlled engineering documentation, protocols, reports, and change recordsSupport sterile barrier system validation activities, including seal strength, integrity, and package performance testingCollaborate cross-functionally with Quality, Manufacturing, and Regulatory teams to ensure release readiness Qualifications: Bachelor’s degree in Engineering3+ years of experience in a regulated medical device environmentHands-on experience with validation and controlled documentationFamiliarity with thermoforming and package sealing processes is a strong plusExperience supporting packaging process validation and product release activities  

Position Summary The Staff, Supplier Engineer will lead the transfer, scale-up, and continuous improvement of manufacturing processes for medical device products. This role serves as the technical lead for contract manufacturers and suppliers, supporting process development, validation, quality, and cost improvement in a regulated environment. Key Responsibilities Act as the primary technical contact for contract manufacturers and suppliers Lead process transfer from R&D to pilot and full production Develop, validate, and improve manufacturing processes and equipment Plan and execute process validations (IQ/OQ/PQ) and maintain validation documentation Create and maintain process risk tools such as PFMEA Support supplier selection, qualification, and capacity planning Drive process improvement, yield enhancement, and cost reduction initiatives Apply lean manufacturing principles to improve flow, efficiency, and quality Collaborate with R&D on design for manufacturability (DFM) Develop tooling, fixtures, work instructions, and inspection plans Lead root cause investigations and corrective actions for manufacturing issues Ensure compliance with FDA, ISO, and quality system requirements Support new product introductions and production ramp-ups Travel occasionally to supplier and manufacturing sites Qualifications Bachelor’s degree in Mechanical Engineering or related field (Master’s preferred) 8+ years of manufacturing/process engineering experience in medical devices or high-volume production Strong experience with process development, validation, and supplier transfer Knowledge of FDA, ISO, and regulated manufacturing environments Experience with lean manufacturing and continuous improvement tools Strong problem-solving and statistical analysis skills (DOE, Cpk, GR&R) Excellent communication and project management skills Preferred Experience Catheter, balloon, or stent manufacturing Braiding, coiling, or laser processing Tooling and fixture design SolidWorks proficiency