Process Engineer II (Medtech)

TL;DR

Process Engineer II (Medtech): Developing and optimizing manufacturing processes for neurovascular medical devices with an accent on new product introductions (NPI) and equipment qualification. Focus on designing production layouts, performing IQ/OQ/PQ validations, and ensuring compliance with FDA regulatory standards.

Location: Onsite in Irvine, CA (Minimum 4 days a week)

Salary: $80,800 - $121,200 USD

Company

A global healthcare technology leader focused on alleviating pain, restoring health, and extending life through advanced medical solutions.

What you will do

• Develop and optimize manufacturing processes for new product introductions in collaboration with R&D, Quality, and Operations.
• Design manufacturing procedures, inspection methods, and production layouts using lean principles and design for manufacturability (DFM).
• Create and support the development of specialized fixtures, tooling, and production equipment.
• Perform equipment and process characterization and qualifications (IQ/OQ/PQ).
• Lead pilot and production builds, including operator training and production planning coordination.
• Troubleshoot assembly and process issues while ensuring strict compliance with FDA and international regulatory standards.

Requirements

• Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering with 2+ years of experience in the medical device industry, OR a Master’s degree in these fields.
• Unrestricted U.S. work authorization is required at the time of hire (sponsorship is not available for this level).
• Proven experience developing products or manufacturing processes within the medical device sector.

Nice to have

• Knowledge of medical-grade polymers (PEEK, PTFE, FEP) and metals (Nitinol, platinum, stainless steel).
• Hands-on experience with reflow, laser bonding, braiding, coil winding, or hydrophilic coating.
• Experience collaborating with external OEM suppliers for component and equipment selection.
• Proficiency in SolidWorks and engineering statistics.
• Knowledge of process FMECA and process control methodologies.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and an Employee Stock Purchase Plan.
• Tuition assistance and reimbursement programs.
• Global well-being program (Simple Steps) and Life insurance.
• Competitive salary combined with the hirify.global Incentive Plan (MIP).