We are actively seeking a Manager OR Senior Manager of Process Development & Manufacturing for a growing medical device company in North County San Diego. The team is passionate about innovation and collaboration, with a focus on developing breakthrough class II/III cardiovascular medical device products.
As the Manager or Senior Manager of Process Development & Manufacturing, you will lead and support new product and development activities, including new process development, manufacturing transfer projects, and team management, with a specific focus on catheter manufacturing and process development. This role offers the chance to work extensively with a cross-functional team in a fast-paced environment.
Responsibilities:
Create and implement new manufacturing processes for disposable medical devices ensuring efficiency, quality, and compliance with industry standards.
Collaborate with suppliers globally to define manufacturing processes, evaluate equipment, and ensure the delivery of high-quality components.
Drive initiatives for both product and process development to enhance overall efficiency and effectiveness.
Manage production builds and optimization, overseeing the entire lifecycle from verification builds to commercial launch, aligning with business goals and timelines.
Cross functionally collaborate with the R&D team to ensure designs are easily manufacturable, providing valuable insights right from the initial phases of the design process.
Identify and procure manufacturing equipment needed, innovating and validating new processes to ensure scalability for increased production.
Develop and manage the department budget, schedules/forecasts, and resources effectively to meet organizational objectives.
Lead and inspire a team of engineers and technicians, providing clear direction and support in executing business activities related to manufacturing.
Qualifications:
Bachelor's Degree in Engineering (Mechanical or Biomedical).
7-15 years of experience in manufacturing and process development in the medical device industry.
Specialized experience in catheter device process development/manufacturing.
Strong technical background in mechanical engineering and process development.
Previous experience managing people, with a few years of engineering management preferred.
Familiarity with Design of Experiments (DoE), Lean Manufacturing, and technology/process transfer.
Knowledge of FDA regulations and quality system requirements.