Sr. Sustaining Engineer

Summary:

The Senior Sustaining Engineer is responsible for leading post-launch support and continuous improvement initiatives for commercialized medical devices. This role ensures products remain compliant with evolving regulations, are reliable in the field, and are cost-effective to manufacture and/or service. The ideal candidate combines deep technical knowledge with a strong understanding of regulatory requirements, manufacturing processes, and cross-functional collaboration.

Essential Duties & Responsibilities:

1. Lead and manage sustaining engineering projects, including performance-related product changes, cost-reduction initiatives, and end-of-life component redesigns.
2. Drive and implement Engineering Change Orders (ECOs) including risk assessments, design verification/validation, and updates to drawings, specifications, and documentation.
3. Serve as the technical lead for investigating product issues (complaints, field returns, or non-conformances), performing root cause analysis, and executing corrective and preventive actions (CAPA).
4. Maintain and update product Design History Files (DHF), Device Master Records (DMR), and risk management documentation (e.g., FMEAs).
5. Collaborate with Quality, Regulatory, Operations, and Supply Chain to ensure product and process compliance with FDA, ISO 13485, and other applicable standards.
6. Identify and qualify alternate components or materials to address obsolescence, supply chain risks, or performance issues.
7. Support manufacturing teams in resolving production issues, improving yields, and enhancing product reliability.

Supervisory Responsibilities:
This person has no direct supervisor responsibilities.

Interaction:
The incumbent interacts with various individuals and departments within the organization, collaborating with project managers and cross-functional teams to support timelines, risk assessments, and resource planning for sustaining projects.

Education and Experience:
* Bachelor's degree in Mechanical Engineering or a related field (e.g., Biomedical Engineering, etc.) is required.
* Master's degree in a relevant engineering field is preferred.
* 6+ years of engineering experience, preferably in the medical device industry with Class II or Class III devices.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills, and Abilities:
* A proven track record of working in a regulated environment with knowledge of design controls, CAPA, and risk management.
* A thorough knowledge of design controls and their implementation throughout the product development lifecycle.
* Expertise in risk management techniques, including hazard analysis, FMEA, FTA, and risk mitigation strategies.
* Comprehensive understanding of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and IEC 60601 standards.
* A strong knowledge of product design, manufacturing processes, materials, and testing methods in the medical device industry.
* Familiarity with root cause analysis tools and methodologies (5 Whys, Ishikawa diagrams, FMEA, DOE).
* Strong project management and organizational skills, with the ability to manage multiple priorities effectively.
* Excellent written and verbal communication skills for clear technical reporting and cross-functional collaboration.
* Proficient in computer-aided design (CAD), documentation management, and statistical analysis tools (e.g., Minitab).
* Proficient in creating clear, concise, and well-organized technical documentation, including requirements specifications, design documents, test plans, and reports.
* Strong analytical and problem-solving ability, with attention to detail and commitment to product quality.
* Ability to work cross-functionally and lead by influence in a matrixed organization.
* Travel may be required (5-20%).

Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. 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 items weighing up to 40 pounds. May require being on one's feet and walking for extended periods of time.

Work Environment:
The work setting is consistent of a typical medical device manufacturing environment with production areas, offices, and cubicles.

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave

The base pay range for this role is $120,000 - $165,000 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.

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.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.