Process Development Engineer

Process Development Engineer - Maple Grove, MN

Join our team as a Process Development Engineer! This role offers the chance to work on next-generation WATCHMAN devices, driving technology solutions from concept to commercialization. Collaborate with cross-functional teams in R&D, Equipment Engineering, Manufacturing, and Design Assurance to develop equipment, inspections, and processes that improve quality and efficiency.

Schedule: Monday-Friday, 8:00 AM - 4:30 PM

Pay: $56 per hour

Key Responsibilities

• Lead development and improvement of equipment, processes, inspections, and development builds
• Drive Human Visual Inspection (HVI) reduction and process improvements for WATCHMAN manufacturing
• Manage processes and key deliverables through Design Verification (DV), Process Verification (PV), and commercial launch
• Collaborate with R&D, Equipment Engineering, Manufacturing, and Design Assurance to influence design specifications and provide Design for Manufacturability (DFM) input
• Develop new assembly and inspection capabilities for complex equipment
• Train, mentor, and guide engineers, technicians, and manufacturing personnel as needed
• Analyze technical data and communicate recommendations clearly
• Solve complex technical problems in a fast-paced, hands-on environment
• Develop, write, and review process validation strategies and deliverables (Experiment Tech Reports, GR&R, TMV, IQ, FMEA, OQ/PQ)
• Serve as a core team member, workstream lead, or extended team member on new product development projects

Quality Responsibilities

• Maintain compliance with all quality system requirements and build quality into all work

Required Qualifications

• Bachelor's degree in Engineering or related technical field
• 4+ years of experience in medical device or regulated industry
• Experience with Automated Inspection and/or Assembly Equipment
• Strong cross-functional collaboration and influence in technical environments
• Expertise in New Product Development, Process Verification, and Validation (TMV, OQ/PQ)
• Skilled in problem solving, root cause analysis, and applying statistics to drive improvements
• Strong written and verbal communication, decision-making, and critical thinking skills
• Ability to travel locally up to 10%

Preferred Qualifications

• Experience with Nitinol manufacturing

Employee Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plans
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD & D Insurance

Apply Now to be part of a team that drives life-changing technology from concept to commercialization!

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

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