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