Sr. Staff Quality Engineer, iovera

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.  

Summary:

The Senior Staff Quality Engineer leads and oversees design changes for both sustaining and new product introductions within the iovera° medical device portfolio, driving critical design change projects in alignment with the company’s strategic objectives and medical device requirements. The position is responsible for delivering electrical and software engineering innovation and expertise in the design and development of complex, handheld, battery-powered electro-mechanical medical devices and their associated accessories. In this role, you will serve as the primary technical contributor and quality representative, ensuring compliance with the Quality Management System (QMS) as well as company regulations, standards, and applicable guidance. Expected to mentor, coach and provide technical guidance to junior Engineering staff members.

Essential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job.  Other duties may be assigned.

Supervisory Responsibilities:

This role has no supervisory responsibilities.

Interaction:

The incumbent works closely with various departments (e.g., QC, QA, Operations, regulatory and within R&D). 

Education and Experience:

• BS Degree or higher in life sciences, biomedical, quality or similar engineering field required
  • Electrical Engineering and Software knowledge preferred 
•  10 years experience in medical device design or like fields required

Knowledge, Skills, and Abilities:

• A practical and working knowledge of ISO 13485, 21 CFR 820, MDR, ISO 14971, IEC 60601-1 and 2, IEC 62304
• Experience with Design Controls, Product Development, Supplier Audits, Remediation

• Detail oriented, well organized and have excellent communication skills
• Able to manage high workload independently
• Data drive- data analysis and decision making
• Work well with cross-functional team and all levels of the organization
• Able to accomplish objectives with minimal supervision

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Duties of this job may involve standing and/or walking, but for most part sitting for extended periods of time. Duties also involve daily keyboard data entry.  Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.  Will need to lift and move boxes of paper and binders weighing up to 20 pounds.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Typical office setting with a laboratory, offices, warehouse, and cubicles.  Noise level is moderate with consistent printer, telephone ringing and conversation.