Sr. Manager, Process Development & Manufacturing Engineering

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.
• Six Sigma Certification preferred.
• CAD software experience (e.g., Solid Works) preferred.