We are actively seeking a 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 of Process & Manufacturing Engineering, 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.
- Six Sigma Certification preferred.
- CAD software experience (e.g., Solid Works) preferred.
