Senior Staff Mechanical Engineer - Medical Device

Research & Development 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.

Responsible for providing mechanical engineering innovation and expertise in the design and development of complex, hand-held, battery-powered, electro-mechanical medical devices and associated accessories. In this role, you will be a key technical contributor in a small, high-powered team focused on taking Pacira Pharmaceutical’s iovera technologies and designs to the next level of performance, leading projects from concept through launch, including post-market technical support.  You will also be expected to mentor, coach, and provide technical guidance to junior Engineering staff members.

 

Responsibilities:

 

  • Design and package complex electro-mechanical systems, and affiliated disposables and collateral with emphasis on system performance, reliability, human factors, workflow, and COGs.
  • Support new product development from initial concept to market release, and post-market technical support.
  • Document all phases of development within the Company’s document control system (e.g., requirements specifications, risk analyses, verification protocols/reports, component specifications, etc.).
  • Establishes, monitors, and controls technical schedules and budgets.
  • Perform feasibility studies, modeling, and analyses to evaluate proposed designs.
  • Perform design and tolerance analyses of models and parts.
  • Work with Manufacturing Engineering to evaluate designs for cost effectiveness and manufacturability.
  • Support the creation and release of manufacturing processes, test methods, and documentation. 
  • Design test equipment and fixtures to support development and manufacturing.
  • Prototype designs using a variety of in-house/3p prototyping methodologies.
  • Work cross-functionally with other departments to ensure projects, designs, and test activities conform to global regulatory and quality requirements.
  • Modify existing designs for improved manufacturability and reliability.
  • Perform root-cause analyses associated with complaints, field returns, and other post-market activities.
  • Draft and submit disclosures relating to new Intellectual Property.
  • Other duties as assigned.

 

Supervisory Responsibilities:

  • This person has no immediate direct supervisor responsibilities but may direct more junior Mechanical Engineers and/or laboratory/mechanical technicians as assigned

Interaction:

  • The incumbent works cross-functionally with various departments (e.g. RA/QA, Operations, manufacturing, marketing, etc., and within R&D).

Qualifications:

  • BS/MS in Mechanical Engineering
  • Minimum 8 years of experience in product development.
  • Minimum 5 years of experience in medical device (or other highly regulated) environment.
  • Extensive experience designing products using 3D CAD design (surfacing, sheet metal, part modeling, assemblies, collaboration techniques, etc.), and product data management (PDM) software—SolidWorks preferred.
  • Proven track record using a variety of design tools and prototyping techniques to develop and transfer to production successful products that pass global compliance requirements.
  • Experience in high-pressure micro-fluidics and/or cryogenic fluid delivery strongly preferred.
  • Experience with COMSOL, or other complex multiphysics simulation software strongly preferred.
  • Experience with design of experiments (DOE), data collection, and data analysis techniques (using Excel, statistical analysis software, etc.).
  • Good knowledge of mechanical principles, including stress and thermal analysis.
  • Proficient with Microsoft Word, Excel, Project, and PowerPoint.
  • Strong analytical and communication skills (written and verbal).
  • Good hands-on laboratory measurement/troubleshooting skills using common bench equipment.
  • Must be knowledgeable with ISO and FDA Quality System and Design Control requirements.
  • Ability to focus on and achieve scheduled milestones and effectively execute on multiple concurrent projects.
  • Must be able to communicate effectively with peers, management, and customers to solve complex technical problems.
  • Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, and governmental regulations.
  • Effective at organizing and presenting information to peers and management.

 

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.