Qualifications
Key Responsibilities:Provide strategic and operational leadership for process development activities related to catheter-based and electromechanical devices.Lead, mentor, and cultivate a high-performing team of engineers and technical professionals.Guide process development from concept through pilot, validation, and commercial-scale manufacturing.Collaborate closely with R&D, Manufacturing, Quality, Regulatory, and Supply Chain teams to ensure smooth product transitions.Establish and enhance process development methodologies, tools, and best practices.Oversee design for manufacturability (DFM), design for assembly (DFA), and process risk management (FMEA).Ensure compliance with FDA, ISO 13485, and relevant global regulatory requirements.Lead process characterization, validation (IQ/OQ/PQ), and continuous improvement initiatives.Manage budgets, timelines, and resource allocation to align with business objectives.Support supplier development, qualification, and technology transfer as required.Requirements:Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, Manufacturing, or a related discipline).10+ years of progressive leadership experience in process development or manufacturing engineering within the medical device sector.Demonstrated expertise with catheter technologies and/or electromechanical medical devices.Strong understanding of medical device regulations, quality systems, and manufacturing validation requirements.Proven capability to lead cross-functional teams and influence senior leadership.Experience in scaling processes from development to high-volume manufacturing.Excellent communication, problem-solving, and decision-making skills.Preferred Qualifications:Master’s degree in Engineering, Science, or Business.Experience with global manufacturing operations.Background in automation, precision assembly, or high-volume disposable and reusable device manufacturing.Lean Manufacturing, Six Sigma, or similar continuous improvement certification.
About the job
Nextern is seeking an experienced Director of Process Development to spearhead the design, optimization, and scaling of manufacturing processes for cutting-edge catheter-based and electromechanical medical devices. This pivotal role requires a strategic leader who can effectively engage with cross-functional teams, ensuring the establishment of robust, compliant, and cost-efficient processes from the initial stages of development all the way through to commercialization.
The successful candidate will possess extensive technical knowledge in medical device process development, exceptional leadership skills, and a proven history of facilitating manufacturing readiness within regulated environments.
About Nextern
Nextern is at the forefront of medical device innovation, dedicated to developing advanced solutions that enhance patient care. Our commitment to excellence drives us to optimize manufacturing processes while maintaining compliance with stringent regulatory standards.
