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A growing, regulated manufacturer is hiring a Production Maintenance Supervisor to lead maintenance operations supporting production, packaging, and aseptic processes. Key Responsibilities: Lead and develop maintenance technicians Oversee preventative maintenance & equipment uptime Manage work orders, scheduling, and spare parts Support audits, investigations, and GMP compliance Drive continuous improvement across operations Requirements: 5+ years in maintenance within a regulated environment (pharma/med device/etc.) Experience supporting aseptic / sterile manufacturing environments Prior leadership experience Strong GMP knowledge Experience with PM/work order systems Solid troubleshooting background

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Overview: This is an opportunity to join a medical device company developing an innovative transcatheter mitral valve replacement (TMVR) system to advance treatment for mitral regurgitation. As a Senior R&D Engineer specializing in heart valves, you will partner with a high-performing, cross-functional team to design and develop the TMVR system with a focus on valve technologies. This role requires strong technical expertise and a strong understanding of the clinical and regulatory framework for heart valve systems. The successful candidate will drive development projects, support key technical decisions, and lead continuous improvement efforts. Responsibilities: Product Development Drive design and development of novel heart valve technologies, with a focus on valve design. Understand customer needs and contribute to the development of product requirements. Lead test method development, fixture design, test method validation, and execution of critical testing, with a focus on implant testing such as hydrodynamic testing, accelerated wear testing, and tissue mechanical testing. Work with Manufacturing teams to ensure seamless technology transfer, production scale-up, and continuous improvement efforts. Technical Expertise Develop and maintain a deep understanding of cardiovascular anatomy and physiology, the latest advancements in heart valve technologies, and relevant medical device regulations. Troubleshoot technical challenges, conduct root cause investigations, and participate in technical design reviews. Testing & Data Analysis Plan, execute, and document engineering evaluations, bench tests, and preclinical studies. Lead verification and validation activities in preparation for regulatory submissions. Analyze data, summarize findings, and present technical conclusions to the team and leadership to drive data-based decisions. Regulatory Compliance Work closely with the Regulatory Affairs team to ensure all heart valve designs and developments comply with applicable regulatory standards and requirements. Collaborate in preparing regulatory submissions. Quality Assurance Collaborate with the Quality Assurance team to establish and maintain robust quality control processes for heart valve manufacturing and testing. Implement and oversee test methods, protocols, and reports to validate the performance and safety of heart valve products. Project Management Develop and manage project plans, while working with internal and external stakeholders to ensure that milestones and deadlines are met. Identify and mitigate risks associated with project timelines and deliverables. Communicate progress and challenges effectively to senior management and relevant stakeholders. Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure alignment with project goals and timelines, encouraging open communication and knowledge sharing. Qualifications: Education Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related technical field; Master's or Ph.D. preferred. Experience Minimum of 5 years of progressive experience in product development and engineering, with at least 3 years in the medical device industry, preferably in interventional or implantable devices. Experience designing, prototyping, and testing complex medical devices. Demonstrated experience solving complex technical problems, leading technical projects, and implementing solutions. Experience with design change management and technology transfer in the medical device space. Knowledge, Skills and Abilities Proven expertise in research, design, prototyping, and testing of interventional medical devices; expertise in structural heart valve development highly preferred. Working knowledge of cardiovascular anatomy and physiology. Strong understanding of materials science, biomechanics, and medical device manufacturing processes (e.g., nitinol, tissue, extrusion, laser processing). Knowledge of regulatory standards and quality systems (e.g., ISO 13485, FDA QSR, IEC 60601). Proficient in CAD tools (e.g., SolidWorks) and design verification tools (e.g., FEA, tolerance analysis); expertise in data analysis and analytical tools such as Minitab. Excellent interpersonal, verbal, and written communication skills. Demonstrated ability to work with cross-functional teams and manage complex projects with internal and external stakeholders. Ability to clearly present technical information to non-technical stakeholders and executive leadership. Proven ability to foster collaboration across R&D, clinical, regulatory, quality, and manufacturing functions.