Director, Manufacturing - Medical Device

Technical Operations San Diego, CA


Description

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.  At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.

This position will be responsible for all aspects of manufacturing, manufacturing engineering, and the production of Pacira’s iovera products. This includes the leadership of in-house operations as well as additional offsite manufacturing locations.

Responsibilities:

  • Responsible for leading the manufacturing transfer of new products from product development as well as oversight of contract manufacturers, as necessary.
  • Responsible for the leadership of the iovera manufacturing, manufacturing engineering, and production teams.
  • Responsible for the operation and management of production lines, including process, documentation, equipment, tools/fixtures, environmental, and personnel.
  • Provide technical support to Supply Chain and Quality teams to resolve material and product non-conformance issues.
  • Ensure work is performed in compliance with Pacira’s Quality
  • Identify and lead process-related cost reduction opportunities within manufacturing.
  • Design test equipment and process assembly fixtures to continuously improve quality, efficiency, reliability, and product cost.
  • Create manufacturing process documentation, verification test plans, protocols and
  • Lead in-depth product and process failure investigations to determine root causes of failures and implement effective corrective and preventive
  • Work with contract manufacturers to ensure processes are in place for building products to high standards in terms of functionality, quality, cycle times, and cost.
  • Lead the planning and execution of product transfer from product development to manufacturing and ensure products are designed for manufacturability.
  • Develop and manage capacity and production planning models to ensure all current and future business requirements are achieved.
  • All other duties as assigned

Supervisory Responsibilities:

This person will have direct supervisory responsibilities 

Interaction:

The incumbent works closely with various departments including Quality, Supply Chain, R&D, and Commercial.

 

Qualifications:

  • BS in Engineering; Mechanical Engineering or related engineering field
  • 10+ years of experience in a manufacturing environment working with mechanical, electrical, and process controls; medical device experience strongly preferred
  • 5+ years managing engineers and production organizations; medical device experience strongly preferred
  • Experience working in an ISO13485 environment and representing manufacturing during internal and external compliance audits
  • Experience with technical and operational oversight of device contract manufacturing sites strongly preferred.
  • Expertise in scaling manufacturing and transferring process lines to multiple sites
  • Product refurbishment process and operational experience preferred
  • Experience working with quality management systems such as Agile or Mastercontrol
  • Demonstrated ability to communicate and work collaboratively across all functional groups
  • Strong hands-on attitude and the ability to spend significant time on the manufacturing floor is a must
  • Exceptional problem-solving skills and the ability to work under tight deadlines
  • Ability to multi-task and manage various priorities, with the willingness to adapt quickly to changes in a dynamic environment
  • Lean and/or Six Sigma experience strongly preferred
  • Strong verbal, written, and presentation skills
  • Demonstrated ability to address and resolve personnel issues
  • Strong working knowledge of MS Office applications including Word, Excel, Powerpoint.  MS Project and Visio strongly preferred.

EEO Statement

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.