Process Engineer

Responsible for developing and supporting production processes, including software loading, testing, assembly, kitting, and packaging operations, while ensuring the timely introduction of capable and proven processes.

Job Requirements:

• Bachelor�s degree in Engineering
• 4+ years of experience in process engineering or related field
• Medical device industry experience
• Experience in design transfer processes
• Experience working with Manufacturing Execution Systems (MES)
• DRM and/or Lean Six Sigma Certification
• Strong background in process development, characterization, and process/equipment qualification (IQ, OQ, PQ)

Preferred Skills:

• Experience supporting Neuromodulation and Pelvic Health Programmers
• Knowledge of risk management processes such as Design and Process Failure Mode and Effects Analysis (FMEA)
• Ability to identify and implement manufacturing improvements to enhance quality, efficiency, and reduce costs

Job Responsibilities:

• Develop device processing, assembly, and packaging methods for assigned product lines
• Execute and support validation/qualification activities including IQ, OQ, PQ, and process characterization
• Collaborate with Quality Engineering to ensure proper process compliance and maintain quality documentation
• Participate in and lead risk management activities, including review of design and process FMEA
• Resolve technical production issues on assigned product lines in finishing, assembly, and packaging operations
• Develop new line layouts and infrastructure to support assigned products
• Recommend and implement manufacturing equipment acquisitions, coordinating with equipment suppliers on specifications and delivery schedules
• Identify and direct improvements in current manufacturing methods to enhance performance and reduce costs
• Lead training efforts for direct and indirect team members
• Ensure all processes and procedures comply with regulatory requirements (21 CFR 820) and internal quality systems
• Provide project updates to senior management, maintain project documentation, project plans, action item registers, and actively manage risks related to cost, quality, and schedule

Pay Details: $38.00 to $51.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance